The following data is part of a premarket notification filed by S & T Medical Technologies, Inc. with the FDA for B&b Bubbler.
| Device ID | K133210 |
| 510k Number | K133210 |
| Device Name: | B&B BUBBLER |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | S & T MEDICAL TECHNOLOGIES, INC. 1954 KELLOGG AVENUE SUITE 100 Carlsbad, CA 92008 |
| Contact | Derick Corrente |
| Correspondent | Derick Corrente S & T MEDICAL TECHNOLOGIES, INC. 1954 KELLOGG AVENUE SUITE 100 Carlsbad, CA 92008 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2014-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850008733055 | K133210 | 000 |
| 00850008733031 | K133210 | 000 |