SubtlePET
System, Tomography, Computed, Emission
Subtle Medical, Inc.
The following data is part of a premarket notification filed by Subtle Medical, Inc. with the FDA for Subtlepet.
Pre-market Notification Details
| Device ID | K182336 |
| 510k Number | K182336 |
| Device Name: | SubtlePET |
| Classification | System, Tomography, Computed, Emission |
| Applicant | Subtle Medical, Inc. 880 Santa Cruz Ave, Suite 200 Menlo Park, CA 94025 |
| Contact | Enhao Gong |
| Correspondent | Terese Bogucki Decus Biomedical Inc. 2342 Shattuck Ave #333 Berkeley, CA 94704 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-28 |
| Decision Date | 2018-11-30 |
| Summary: | summary |
Trademark Results [SubtlePET]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUBTLEPET 97024314 not registered Live/Pending |
Subtle Medical, Inc. 2021-09-13 |
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