OHMEDA AUXILIARY POWER SYSTEM— 510(k) K863208

Name: FDA 510(k) clearance K863208
Creator: U.S. Food and Drug Administration
Published: 1986-10-03

Substantially Equivalent

Ohmeda Medical

FDA 510(k) clearance K863208 for OHMEDA AUXILIARY POWER SYSTEM, Substantially Equivalent on 1986-10-03. Applicant: Ohmeda Medical. Device class: 2.

Clearance details

Applicant: Ohmeda Medical
Product code: Code FMT
Device class: Class 2
Regulation: 21 CFR 880.5130
Advisory panel: General Hospital
Date received: 1986-08-19
Decision date: 1986-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ohmeda Medical

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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 FMT

product code FMT

Death: 4
Malfunction: 3,074
Total: 3,078

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.