The following data is part of a premarket notification filed by Flosonics Medical with the FDA for Flopatch Fp120.
| Device ID | K222242 |
| 510k Number | K222242 |
| Device Name: | FloPatch FP120 |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | Flosonics Medical 325 Front St W, Floor 4 Toronto, CA M5V 2Y1 |
| Contact | Caleb Chin |
| Correspondent | Caleb Chin Flosonics Medical 325 Front St W, Floor 4 Toronto, CA M5V 2Y1 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-26 |
| Decision Date | 2022-12-09 |