Cleared Traditional

NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)

K970460 · Puritan Bennett Corp. · Anesthesiology
Apr 1998
Decision
448d
Days
Class 2
Risk

About This 510(k) Submission

K970460 is an FDA 510(k) clearance for the NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (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 April 30, 1998, 448 days after receiving the submission on February 6, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K970460 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 1997
Decision Date April 30, 1998
Days to Decision 448 days
Submission Type Traditional
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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