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All.health, Inc. ALGO-m1000-SW (rev 0) Algo SaMD

Company Name

All.health, Inc.

Catalog Number

ALGO-m1000-SW (rev 0)

Description

The all.health Algo SaMD™ Model 1000 oximeter is a pulse oximeter configured to operate in Software as a Medical Device (“SaMD”). The software device is intended to run remotely as an optional cloud service component of a complete all.health ICM™ system, a non-medical-device clinical decision support system. The software device collects input from compatible remote hardware sensor bands or other sensors, then filters, analyzes, and validates the collected data to produce a clinical-grade pulse measurement of heart rate (HRp), respiration rate (RRp), and blood oxygenation (SpO2%) for output, including outlier rejection, averages, trends, and ranges over time for the purpose of remote patient monitoring. Medical Device Info. • Class II (enforcement discretion) medical device • Regulation: Oximeter, 870.2700 • Rx. Federal law (USA) restricts this product to sale by or on the order of a licensed practitioner.

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Additional Details

Device Identifier

00860010157008

Is RX

Yes

Is Over the Counter

No

Requires Sterilization

No

Is Sterile

No

Is Single Use

No

Categories

Barcode Mapping

Unit of Measurement	Eaches	GTIN
Each	1	00860010157008