The following data is part of a premarket notification filed by Subtle Medical, Inc. with the FDA for Subtlemr.
Device ID | K203182 |
510k Number | K203182 |
Device Name: | SubtleMR |
Classification | System, Image Processing, Radiological |
Applicant | Subtle Medical, Inc. 883 Santa Cruz Ave Suite 205 Menlo Park, CA 94025 |
Contact | Ajit Shankaranarayanan |
Correspondent | Jared Seehafer Enzyme Corporation 611 Gateway Blvd #120 South San Francisco, CA 94080 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-10-27 |
Decision Date | 2021-02-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SUBTLEMR 97024929 not registered Live/Pending |
Subtle Medical, Inc. 2021-09-13 |