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 |