Cleared Special

PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION

K984535 · Puritan Bennett Corp. · Anesthesiology
Dec 1998
Decision
7d
Days
Class 2
Risk

About This 510(k) Submission

K984535 is an FDA 510(k) clearance for the PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL 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 December 28, 1998, 7 days after receiving the submission on December 21, 1998. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K984535 FDA.gov
FDA Decision Cleared ST
Date Received December 21, 1998
Decision Date December 28, 1998
Days to Decision 7 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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