The following data is part of a premarket notification filed by Biotricity Inc. with the FDA for Bioflux Software.
| Device ID | K162571 |
| 510k Number | K162571 |
| Device Name: | Bioflux Software |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | Biotricity Inc. 75 International Blvd, Suite 300 Toronto, CA M9w 6l9 |
| Contact | Tom Elias |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-09-15 |
| Decision Date | 2016-10-13 |
| Summary: | summary |