The following data is part of a premarket notification filed by Braebon Medical Corp. with the FDA for Medibyte, Model Mp8.
| Device ID | K061764 |
| 510k Number | K061764 |
| Device Name: | MEDIBYTE, MODEL MP8 |
| 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 | 2006-06-22 |
| Decision Date | 2006-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B14189000 | K061764 | 000 |
| B14088970 | K061764 | 000 |
| B14088960 | K061764 | 000 |
| B14088950 | K061764 | 000 |
| B1408889210 | K061764 | 000 |
| B14086201 | K061764 | 000 |
| B14086200FM1 | K061764 | 000 |
| B14086110 | K061764 | 000 |
| B14086120 | K061764 | 000 |
| B14088980 | K061764 | 000 |
| B14088990 | K061764 | 000 |
| B140MBJRK0 | K061764 | 000 |
| B140MP8WN0 | K061764 | 000 |
| B140MP8W0 | K061764 | 000 |
| B140MP8U0 | K061764 | 000 |
| B140MP8KN0 | K061764 | 000 |
| B140MP8KLITE0 | K061764 | 000 |
| B140MBJRWN0 | K061764 | 000 |
| B140MBJRW0 | K061764 | 000 |
| B140MBJRU0 | K061764 | 000 |
| B14088900 | K061764 | 000 |