Cleared Traditional

MODEL 7200AE VENTILATOR

K922705 · Puritan Bennett Corp. · Anesthesiology
Sep 1994
Decision
839d
Days
Class 2
Risk

About This 510(k) Submission

K922705 is an FDA 510(k) clearance for the MODEL 7200AE VENTILATOR, 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, 839 days after receiving the submission on June 5, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K922705 FDA.gov
FDA Decision Cleared ST
Date Received June 05, 1992
Decision Date September 22, 1994
Days to Decision 839 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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