The following data is part of a premarket notification filed by Braebon Medical Corp. with the FDA for Ultima Respiratory Effort Sensor Models 0520 And 0522.
| Device ID | K982216 |
| 510k Number | K982216 |
| Device Name: | ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 |
| Classification | Monitor, Breathing Frequency |
| 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 | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-23 |
| Decision Date | 1998-09-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B14055270 | K982216 | 000 |
| B14005220 | K982216 | 000 |
| B140052310 | K982216 | 000 |
| B140052320 | K982216 | 000 |
| B140052330 | K982216 | 000 |
| B140052340 | K982216 | 000 |
| B140052350 | K982216 | 000 |
| B140052610 | K982216 | 000 |
| B140052620 | K982216 | 000 |
| B140052630 | K982216 | 000 |
| B140052640 | K982216 | 000 |
| B140052650 | K982216 | 000 |
| B14005280 | K982216 | 000 |
| B1400528A0 | K982216 | 000 |
| B1400528A40 | K982216 | 000 |
| B14005290 | K982216 | 000 |
| B14005200 | K982216 | 000 |