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K Number
K953461
Device Name
CPR MASK & RELATED FAMILY KITS
Manufacturer
SAFETEC OF AMERICA, INC.
Date Cleared
1996-01-04

(164 days)

Product Code
CBP
Regulation Number
868.5870
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.5870 Nonrebreathing valve.

(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).