Cleared Traditional

PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM

K942210 · Puritan Bennett Corp. · Anesthesiology
Feb 1996
Decision
647d
Days
Class 2
Risk

About This 510(k) Submission

K942210 is an FDA 510(k) clearance for the PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM, a Ventilator, Continuous, Non-life-supporting (Class II — Special Controls, product code MNS), submitted by Puritan Bennett Corp. (Lenexa, US). The FDA issued a Cleared decision on February 9, 1996, 647 days after receiving the submission on May 3, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K942210 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 1994
Decision Date February 09, 1996
Days to Decision 647 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MNS — Ventilator, Continuous, Non-life-supporting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895