Cleared Traditional

BAGRIGHT INFANT RESUSCITATOR

K961330 · Medical Marketing Concepts · Anesthesiology
Jul 1996
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K961330 is an FDA 510(k) clearance for the BAGRIGHT INFANT RESUSCITATOR, a Ventilator, Emergency, Manual (resuscitator) (Class II — Special Controls, product code BTM), submitted by Medical Marketing Concepts (Roanoke, US). The FDA issued a Cleared decision on July 2, 1996, 85 days after receiving the submission on April 8, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5915.

Submission Details

510(k) Number K961330 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 1996
Decision Date July 02, 1996
Days to Decision 85 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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