Cleared Traditional

MODEL 7200AE VENTILATOR (ENHANCEMENT)

K922975 · Puritan Bennett Corp. · Anesthesiology
Sep 1994
Decision
822d
Days
Class 2
Risk

About This 510(k) Submission

K922975 is an FDA 510(k) clearance for the MODEL 7200AE VENTILATOR (ENHANCEMENT), 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, 822 days after receiving the submission on June 22, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K922975 FDA.gov
FDA Decision Cleared ST
Date Received June 22, 1992
Decision Date September 22, 1994
Days to Decision 822 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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