Cleared Traditional

HUMID-VENT HEPA

K112958 · Teleflex Medical · General Hospital
Sep 2012
Decision
352d
Days
Class 2
Risk

About This 510(k) Submission

K112958 is an FDA 510(k) clearance for the HUMID-VENT HEPA, a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by Teleflex Medical (Durham, US). The FDA issued a Cleared decision on September 21, 2012, 352 days after receiving the submission on October 5, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number K112958 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 2011
Decision Date September 21, 2012
Days to Decision 352 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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