Affinity
System, Tomography, Computed, Emission
Hermes Medical Solutions AB
The following data is part of a premarket notification filed by Hermes Medical Solutions Ab with the FDA for Affinity.
Pre-market Notification Details
| Device ID | K193152 |
| 510k Number | K193152 |
| Device Name: | Affinity |
| Classification | System, Tomography, Computed, Emission |
| Applicant | Hermes Medical Solutions AB Strandbergsgatan 16 Stockholm, SE 11251 |
| Contact | Joakim Arwidson |
| Correspondent | Joakim Arwidson Hermes Medical Solutions AB Strandbergsgatan 16 Stockholm, SE 11251 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-13 |
| Decision Date | 2020-02-14 |
Trademark Results [Affinity]
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.