OHMEDA - LOGIC 07A TRANSPORT VENTILATOR— 510(k) K901846

Name: FDA 510(k) clearance K901846
Creator: U.S. Food and Drug Administration
Published: 1990-08-08

Substantially Equivalent

Ohmeda Medical

FDA 510(k) clearance K901846 for OHMEDA - LOGIC 07A TRANSPORT VENTILATOR, Substantially Equivalent on 1990-08-08. Applicant: Ohmeda Medical. Device class: 2.

Clearance details

Applicant: Ohmeda Medical
Product code: Code BTL
Device class: Class 2
Regulation: 21 CFR 868.5925
Advisory panel: Anesthesiology
Date received: 1990-04-24
Decision date: 1990-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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K101788 — GIRAFFE OMNIBED2010-07-21
K090697 — MODIFICATION TO: GIRAFFE AND PANDA WARMER2009-04-16
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Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.