Cleared Traditional

VENTNET; CENTRAL MONITORING STATION

K963633 · Puritan Bennett Corp. · Anesthesiology
Dec 1996
Decision
96d
Days
Class 2
Risk

About This 510(k) Submission

K963633 is an FDA 510(k) clearance for the VENTNET; CENTRAL MONITORING STATION, a Accessory To Continuous Ventilator (respirator) (Class II — Special Controls, product code MOD), submitted by Puritan Bennett Corp. (Tustin, US). The FDA issued a Cleared decision on December 16, 1996, 96 days after receiving the submission on September 11, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K963633 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 1996
Decision Date December 16, 1996
Days to Decision 96 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MOD — Accessory To Continuous Ventilator (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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