Cleared Traditional

NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM

K964540 · Puritan Bennett Corp. · Anesthesiology
Nov 1997
Decision
367d
Days
Class 2
Risk

About This 510(k) Submission

K964540 is an FDA 510(k) clearance for the NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM, 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 14, 1997, 367 days after receiving the submission on November 12, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K964540 FDA.gov
FDA Decision Cleared ST
Date Received November 12, 1996
Decision Date November 14, 1997
Days to Decision 367 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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