The following data is part of a premarket notification filed by Braebon Medical Corp. with the FDA for Ultima Smartbelt, Model 0560.
| Device ID | K001743 |
| 510k Number | K001743 |
| Device Name: | ULTIMA SMARTBELT, MODEL 0560 |
| Classification | Monitor, Breathing Frequency |
| 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 | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-08 |
| Decision Date | 2000-08-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B14085790 | K001743 | 000 |
| B14003570 | K001743 | 000 |
| B14003560 | K001743 | 000 |
| B14003550 | K001743 | 000 |
| B14003540 | K001743 | 000 |
| B14003530 | K001743 | 000 |
| B14003500 | K001743 | 000 |
| B14085780 | K001743 | 000 |
| B14055710 | K001743 | 000 |
| B14005780 | K001743 | 000 |
| B14005670 | K001743 | 000 |
| B14085920 | K001743 | 000 |
| B1408592A0 | K001743 | 000 |
| B1400573A0 | K001743 | 000 |
| B1400572APED0 | K001743 | 000 |
| B1400572AL0 | K001743 | 000 |
| B14003580 | K001743 | 000 |
| B14003590 | K001743 | 000 |
| B14085740 | K001743 | 000 |
| B1408572PED0 | K001743 | 000 |
| B14085720 | K001743 | 000 |
| B14055770 | K001743 | 000 |
| B1405573241 | K001743 | 000 |
| B1405572241 | K001743 | 000 |
| B1405571241 | K001743 | 000 |
| B14005790 | K001743 | 000 |
| B14005740 | K001743 | 000 |
| B14005730 | K001743 | 000 |
| B1400572PED0 | K001743 | 000 |
| B1400572L0 | K001743 | 000 |
| B14005720 | K001743 | 000 |
| B140057120 | K001743 | 000 |
| B140057020 | K001743 | 000 |
| B1400572A0 | K001743 | 000 |