The following data is part of a premarket notification filed by Braebon Medical Corp. with the FDA for Ultima Airflow Pressure Sensor.
| Device ID | K984431 |
| 510k Number | K984431 |
| Device Name: | ULTIMA AIRFLOW PRESSURE SENSOR |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-11 |
| Decision Date | 1998-12-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B14055810 | K984431 | 000 |
| B14005850 | K984431 | 000 |
| B14005800 | K984431 | 000 |
| B1400580A0 | K984431 | 000 |
| B1400580D0 | K984431 | 000 |
| B1400580L0 | K984431 | 000 |
| B1400580NOX0 | K984431 | 000 |
| B1400580PES0 | K984431 | 000 |
| B14005810 | K984431 | 000 |
| B1400581L0 | K984431 | 000 |
| B14005840 | K984431 | 000 |
| B14005920 | K984431 | 000 |
| B14005930 | K984431 | 000 |
| B1400585PESXA0 | K984431 | 000 |