Cleared Traditional

B&B BUBBLER

K133210 · S & T Medical Technologies, Inc. · Anesthesiology

Mar 2014

Decision

162d

Days

Class 2

Risk

About This 510(k) Submission

K133210 is an FDA 510(k) clearance for the B&B BUBBLER, a Attachment, Breathing, Positive End Expiratory Pressure (Class II — Special Controls, product code BYE), submitted by S & T Medical Technologies, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 28, 2014, 162 days after receiving the submission on October 17, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5965.

Submission Details

510(k) Number	K133210 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 17, 2013
Decision Date	March 28, 2014
Days to Decision	162 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement