Cleared Traditional

DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR

K030990 · Datex-Ohmeda · General Hospital
Jun 2003
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K030990 is an FDA 510(k) clearance for the DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR, 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 25, 2003, 89 days after receiving the submission on March 28, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number K030990 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2003
Decision Date June 25, 2003
Days to Decision 89 days
Submission Type Traditional
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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