Cleared Special

PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840

K993071 · Puritan Bennett Corp. · Anesthesiology
Nov 1999
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K993071 is an FDA 510(k) clearance for the PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840, 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 November 24, 1999, 71 days after receiving the submission on September 14, 1999. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K993071 FDA.gov
FDA Decision Cleared ST
Date Received September 14, 1999
Decision Date November 24, 1999
Days to Decision 71 days
Submission Type Special
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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