The following data is part of a premarket notification filed by Biotricity with the FDA for Biotres.
| Device ID | K222017 |
| 510k Number | K222017 |
| Device Name: | Biotres |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | Biotricity 203 Redwood Shores Pkwy Suite 600 Redwood City, CA 94065 |
| Contact | Spencer LaDow |
| Correspondent | Spencer LaDow Biotricity 203 Redwood Shores Pkwy Suite 600 Redwood City, CA 94065 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-08 |
| Decision Date | 2022-07-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BIOTRES 97193603 not registered Live/Pending |
Biotricity Inc. 2021-12-28 |
![]() BIOTRES 73264004 1179777 Dead/Cancelled |
Central Pharmacal Company, The 1980-05-29 |