MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER)— 510(k) K881614

Name: FDA 510(k) clearance K881614
Creator: U.S. Food and Drug Administration
Published: 1988-04-29

Substantially Equivalent

Ohmeda Medical

FDA 510(k) clearance K881614 for MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER), Substantially Equivalent on 1988-04-29. Applicant: Ohmeda Medical. Device class: 2.

Clearance details

Applicant: Ohmeda Medical
Product code: Code BYE
Device class: Class 2
Regulation: 21 CFR 868.5965
Advisory panel: Anesthesiology
Date received: 1988-04-12
Decision date: 1988-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BYE

view all

K160112 — Besmed PEEP Valve2016-04-29
K133957 — DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE2014-04-14
K133210 — B&B BUBBLER2014-03-28
K122610 — PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES2013-08-05
K112546 — O_TWO CPAP SYSTEM2011-12-27

More clearances from Ohmeda Medical

view all

K123309 — GIRAFFE AND PANDA WARMERS2013-02-05
K101778 — GIRAFFE INCUBATOR2010-07-21
K101788 — GIRAFFE OMNIBED2010-07-21
K090697 — MODIFICATION TO: GIRAFFE AND PANDA WARMER2009-04-16
K072157 — MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)2007-08-27

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.