Cleared Special

DATEX-OHMEDA HMEF 750

K031653 · Datex-Ohmeda · General Hospital
Jun 2003
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K031653 is an FDA 510(k) clearance for the DATEX-OHMEDA HMEF 750, a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on June 20, 2003, 23 days after receiving the submission on May 28, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number K031653 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2003
Decision Date June 20, 2003
Days to Decision 23 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code CAH — Filter, Bacterial, Breathing-circuit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5260

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