Cleared Traditional

PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR)

K944347 · Puritan Bennett Corp. · Anesthesiology
Dec 1994
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K944347 is an FDA 510(k) clearance for the PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR), a Ventilator, Emergency, Manual (resuscitator) (Class II — Special Controls, product code BTM), submitted by Puritan Bennett Corp. (Lenexa, US). The FDA issued a Cleared decision on December 12, 1994, 97 days after receiving the submission on September 6, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5915.

Submission Details

510(k) Number K944347 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 1994
Decision Date December 12, 1994
Days to Decision 97 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BTM — Ventilator, Emergency, Manual (resuscitator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5915

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