The following data is part of a premarket notification filed by Flosonics Medical (r/a 1929803 Ontario Corp.) with the FDA for Flopatch (fp120).
| Device ID | K200337 |
| 510k Number | K200337 |
| Device Name: | FloPatch (FP120) |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | Flosonics Medical (r/a 1929803 Ontario Corp.) 325 Front St W, Fourth Floor, OneEleven Toronto, CA M5v 2y1 |
| Contact | Andrew Eibl |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-02-11 |
| Decision Date | 2020-03-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20627987360114 | K200337 | 000 |
| 00627987360103 | K200337 | 000 |
| 00627987360127 | K200337 | 000 |
| 10627987360117 | K200337 | 000 |