The following data is part of a premarket notification filed by Braebon Medical Corp. with the FDA for Ultima Airflow Sensor, 0510.
| Device ID | K981445 |
| 510k Number | K981445 |
| Device Name: | ULTIMA AIRFLOW SENSOR, 0510 |
| 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 | 1998-04-22 |
| Decision Date | 1998-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B140B12210 | K981445 | 000 |
| B14005140 | K981445 | 000 |
| B1400510SE0 | K981445 | 000 |
| B1400510PED0 | K981445 | 000 |
| B1400510BS0 | K981445 | 000 |
| B1400510A60 | K981445 | 000 |
| B1400510A50 | K981445 | 000 |
| B1400510A40 | K981445 | 000 |
| B1400510A0 | K981445 | 000 |
| B14005100 | K981445 | 000 |
| B1408514L0 | K981445 | 000 |
| B1400512BS0 | K981445 | 000 |
| B1400514A30 | K981445 | 000 |
| B1400514A40 | K981445 | 000 |
| B1400514A50 | K981445 | 000 |
| B14085140 | K981445 | 000 |
| B1408510BS0 | K981445 | 000 |
| B14055120 | K981445 | 000 |
| B1400518241 | K981445 | 000 |
| B1400517241 | K981445 | 000 |
| B14005150 | K981445 | 000 |
| B1400514SE0 | K981445 | 000 |
| B1400514PED0 | K981445 | 000 |
| B1400514A6PED0 | K981445 | 000 |
| B1400514A60 | K981445 | 000 |
| B1400514A5PED0 | K981445 | 000 |
| B1400514A0 | K981445 | 000 |