Cleared Traditional

THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM

K960518 · Puritan Bennett Corp. · Anesthesiology
May 1996
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K960518 is an FDA 510(k) clearance for the THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Puritan Bennett Corp. (Lenexa, US). The FDA issued a Cleared decision on May 9, 1996, 94 days after receiving the submission on February 5, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K960518 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 1996
Decision Date May 09, 1996
Days to Decision 94 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZD — Ventilator, Non-continuous (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

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