MORTARA INSTRUMENT, INC. 9922-019-50 SunTech Tango M2 Kit

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

M2 Revive Console

The KKT-M2 device is to be used in the aid of management of chronic pain due to non-congenital defects. The device can be used as part of a series of steps in the total care of the patient. The procedure involves the use of diagnostic imaging that qualifies the misalignment between vertebrae. The treatment is then administered using the KKT-M2 device to deliver precise impulses at a required vector configuration.

PeakSonic M2 is a handheld portable bladder volume instrument, which can be applied in the department of Surgery, Emergency, ICU, Obstetric, Gynecology, radiotherapy and nursing home. It can provide the basis for clinical catheterization, evaluate the post-void residual after patient urination, and make auxiliary diagnosis on the bladder and kidney diseases. The system is also suitable for patients of lower body disability or loss of auto-urination function, to confirm the proper timing of urination.

BIO-COMP CRKSCRW FT VENTD 5.5X14.7MM

SCREW, CANN. INT., FULL THREAD

SCRW,CANN. INT.,W/DISP SHTH

TIGHTROPE ABS, BUTTON, 8 X 12 MM

The Stat Profile Prime Plus Blood Analyzer is a compact, whole blood critical care analyzer that provides rapid and comprehensive results. It measures blood gases, electrolytes, metabolites, and co-oximetry, delivering 32 calculated results. Featuring maintenance-free, replaceable cartridge technology and patented non-lysing co-oximetry, the analyzer produces a complete test panel in about one minute. It also offers bidirectional connectivity and a powerful onboard data management system for efficient data handling and integration

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

M2 Revive Console

The KKT-M2 device is to be used in the aid of management of chronic pain due to non-congenital defects. The device can be used as part of a series of steps in the total care of the patient. The procedure involves the use of diagnostic imaging that qualifies the misalignment between vertebrae. The treatment is then administered using the KKT-M2 device to deliver precise impulses at a required vector configuration.

PeakSonic M2 is a handheld portable bladder volume instrument, which can be applied in the department of Surgery, Emergency, ICU, Obstetric, Gynecology, radiotherapy and nursing home. It can provide the basis for clinical catheterization, evaluate the post-void residual after patient urination, and make auxiliary diagnosis on the bladder and kidney diseases. The system is also suitable for patients of lower body disability or loss of auto-urination function, to confirm the proper timing of urination.