CPR MASK & RELATED FAMILY KITS

K953461 · Safetec of America, Inc. · CBP · Jan 4, 1996 · Anesthesiology

Device Facts

Record IDK953461
Device NameCPR MASK & RELATED FAMILY KITS
ApplicantSafetec of America, Inc.
Product CodeCBP · Anesthesiology
Decision DateJan 4, 1996
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 868.5870
Device ClassClass 2

Regulatory Classification

Identification

A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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