Cleared Traditional

DISPOSABLE BACTERIAL BREATHNG FILTER

K915750 · Hospitak, Inc. · General Hospital
Nov 1994
Decision
1077d
Days
Class 2
Risk

About This 510(k) Submission

K915750 is an FDA 510(k) clearance for the DISPOSABLE BACTERIAL BREATHNG FILTER, a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by Hospitak, Inc. (Lindenhurst, US). The FDA issued a Cleared decision on November 30, 1994, 1077 days after receiving the submission on December 19, 1991. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number K915750 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 1991
Decision Date November 30, 1994
Days to Decision 1077 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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