Biotres
Electrocardiograph, Ambulatory (without Analysis)
Biotricity
The following data is part of a premarket notification filed by Biotricity with the FDA for Biotres.
Pre-market Notification Details
| Device ID | K211709 |
| 510k Number | K211709 |
| Device Name: | Biotres |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| 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 | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-03 |
| Decision Date | 2022-01-19 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B635BIOTRES100 | K211709 | 000 |
| B635BIOTRESPR0 | K211709 | 000 |
Trademark Results [Biotres]
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 |
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