Cleared Traditional

ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT

K954828 · Gibeck, Inc. · General Hospital
May 1996
Decision
195d
Days
Class 2
Risk

About This 510(k) Submission

K954828 is an FDA 510(k) clearance for the ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT, a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by Gibeck, Inc. (Indianapolis, US). The FDA issued a Cleared decision on May 2, 1996, 195 days after receiving the submission on October 20, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number K954828 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 1995
Decision Date May 02, 1996
Days to Decision 195 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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