Cleared Traditional

BAGRIGHT RESPOSABLE CHILD RESUSCITATOR

K961331 · Medical Marketing Concepts · Anesthesiology
Jun 1996
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K961331 is an FDA 510(k) clearance for the BAGRIGHT RESPOSABLE CHILD 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 June 28, 1996, 81 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 K961331 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 1996
Decision Date June 28, 1996
Days to Decision 81 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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