PEEP VALVE— 510(k) K961867

Name: FDA 510(k) clearance K961867
Creator: U.S. Food and Drug Administration
Published: 1996-08-13

Substantially Equivalent

Medical Marketing Concepts

FDA 510(k) clearance K961867 for PEEP VALVE, Substantially Equivalent on 1996-08-13. Applicant: Medical Marketing Concepts. Device class: 2.

Clearance details

Applicant: Medical Marketing Concepts
Product code: Code BYE
Device class: Class 2
Regulation: 21 CFR 868.5965
Advisory panel: Anesthesiology
Date received: 1996-05-15
Decision date: 1996-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roanoke, VA, US

Download summary PDF View on FDA.gov ↗

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K112546 — O_TWO CPAP SYSTEM2011-12-27

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K982215 — MANUAL RESUSCITATOR WITH ACE1998-09-18
K961329 — BAGRIGHT CHILD RESUSCITATOR1996-07-02
K961330 — BAGRIGHT INFANT RESUSCITATOR1996-07-02
K961331 — BAGRIGHT RESPOSABLE CHILD RESUSCITATOR1996-06-28
K961332 — BAGRIGHT RESPOSABLE INFANT RESUSCITATOR1996-06-28

Adverse events under product code BYE

product code BYE

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.