Cleared Traditional

PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION

K001646 · Puritan Bennett Corp. · Anesthesiology
Oct 2000
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K001646 is an FDA 510(k) clearance for the PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION, 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 October 20, 2000, 143 days after receiving the submission on May 30, 2000. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K001646 FDA.gov
FDA Decision Cleared ST
Date Received May 30, 2000
Decision Date October 20, 2000
Days to Decision 143 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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