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K Number
K073171
Device Name
RESUSCITATION TIMER, MODEL L770-CPR
Manufacturer
ALLIED HEALTHCARE PRODUCTS, INC.
Date Cleared
2008-01-31

(83 days)

Product Code
BTM
Regulation Number
868.5915
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.5915 Manual emergency ventilator.

(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).