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K Number
K010577

Validate with FDA (Live)

Device Name
BODYGEM, MODEL HB211
Manufacturer
HEALTHETECH, INC.
Date Cleared
2002-01-10

(317 days)

Product Code
BZL
Regulation Number
868.1730
Type
Traditional
Panel
Anesthesiology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K021490
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 868.1730 Oxygen uptake computer.

(a)
Identification. An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a patient and may include components for determining expired gas volume and composition.(b)
Classification. Class II (performance standards).