Cleared Traditional

AUTO-PEEP

K924043 · Puritan Bennett Corp. · Anesthesiology
Sep 1994
Decision
772d
Days
Class 2
Risk

About This 510(k) Submission

K924043 is an FDA 510(k) clearance for the AUTO-PEEP, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Puritan Bennett Corp. (Carlsbad, US). The FDA issued a Cleared decision on September 22, 1994, 772 days after receiving the submission on August 11, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K924043 FDA.gov
FDA Decision Cleared ST
Date Received August 11, 1992
Decision Date September 22, 1994
Days to Decision 772 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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