The following data is part of a premarket notification filed by Braebon Medical Corp. with the FDA for Ultima Snoring Mike, Model 0540.
| Device ID | K020312 |
| 510k Number | K020312 |
| Device Name: | ULTIMA SNORING MIKE, MODEL 0540 |
| Classification | Ventilatory Effort Recorder |
| Applicant | BRAEBON MEDICAL CORP. 120 WALGREEN DR (RR#3) SUITE #1 Carp, Ontario, CA K0a 1l0 |
| Contact | Richard A Bonato |
| Correspondent | Richard A Bonato BRAEBON MEDICAL CORP. 120 WALGREEN DR (RR#3) SUITE #1 Carp, Ontario, CA K0a 1l0 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-30 |
| Decision Date | 2002-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B14085410 | K020312 | 000 |
| B14005460 | K020312 | 000 |
| B14005450 | K020312 | 000 |
| B14005440 | K020312 | 000 |
| B14005420 | K020312 | 000 |
| B14005400 | K020312 | 000 |
| B14005430 | K020312 | 000 |