The following data is part of a premarket notification filed by Biotricity Inc. with the FDA for Bioflux Device.
| Device ID | K172311 |
| 510k Number | K172311 |
| Device Name: | BioFlux Device |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | Biotricity Inc. 275 Shoreline Drive, Suite 150 Redwood City, CA 94065 |
| Contact | Spencer Ladow |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-08-01 |
| Decision Date | 2017-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B635BIOFLUX101 | K172311 | 000 |
| B635BIOFLUX1A0 | K172311 | 000 |