Cleared Special

VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840

K063650 · Puritan Bennett Corp. · Anesthesiology
Feb 2007
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K063650 is an FDA 510(k) clearance for the VENTILATOR WITH RESPIRATORY MECHANICS, 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 February 15, 2007, 69 days after receiving the submission on December 8, 2006. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K063650 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 2006
Decision Date February 15, 2007
Days to Decision 69 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

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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