Cleared Traditional

K961332 - BAGRIGHT RESPOSABLE INFANT RESUSCITATOR
(FDA 510(k) Clearance)

K961332 · Medical Marketing Concepts · Anesthesiology

Jun 1996

Decision

81d

Days

Class 2

Risk

K961332 is an FDA 510(k) clearance for the BAGRIGHT RESPOSABLE INFANT RESUSCITATOR. This device is classified as 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 FDA review panel. Regulated under 21 CFR 868.5915.

Submission Details

510(k) Number	K961332 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