The following data is part of a premarket notification filed by Flosonics Medical (r/a 1929803 Ontario Corp.) with the FDA for Flopatch (fp110).
| Device ID | K191388 |
| 510k Number | K191388 |
| Device Name: | FloPatch (FP110) |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | Flosonics Medical (r/a 1929803 Ontario Corp.) 204-73 Elm Street Sudbury, CA P3c 1r7 |
| Contact | Joe Eibl |
| Correspondent | Mark Job 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 | 2019-05-24 |
| Decision Date | 2019-06-21 |