The following data is part of a premarket notification filed by Braebon Medical Corp. with the FDA for Ultima Body Position Sensor.
| Device ID | K981969 |
| 510k Number | K981969 |
| Device Name: | ULTIMA BODY POSITION SENSOR |
| Classification | Device, Sleep Assessment |
| Applicant | BRAEBON MEDICAL CORP. 63 ACKLAM TERRACE Kanata, CA K2k 2h7 |
| Contact | Richard A Bonato |
| Correspondent | Richard A Bonato BRAEBON MEDICAL CORP. 63 ACKLAM TERRACE Kanata, CA K2k 2h7 |
| Product Code | LEL |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-04 |
| Decision Date | 1998-08-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B14005340 | K981969 | 000 |
| B14005330 | K981969 | 000 |
| B14005320 | K981969 | 000 |
| B14005310 | K981969 | 000 |
| B1400530M0 | K981969 | 000 |
| B14005300 | K981969 | 000 |
| B1400533XA0 | K981969 | 000 |
| B1400532XA0 | K981969 | 000 |