The following data is part of a premarket notification filed by Biotricity with the FDA for Bioflux Software Ii.
| Device ID | K201040 |
| 510k Number | K201040 |
| Device Name: | Bioflux Software II |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | Biotricity 275 Shoreline Drive, Suite 150 Redwood City, CA 94065 |
| Contact | Spencer Ladow |
| Correspondent | Spencer Ladow Biotricity 275 Shoreline Drive, Suite 150 Redwood City, CA 94065 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-01 |
| Decision Date | 2020-07-29 |