The following data is part of a premarket notification filed by Hermes Medical Solutions Ab with the FDA for Olinda Exm.
| Device ID | K163687 |
| 510k Number | K163687 |
| Device Name: | OLINDA EXM |
| Classification | Camera, Scintillation (gamma) |
| Applicant | Hermes Medical Solutions AB Skeppsbron 44 Stockholm, SE 11130 |
| Contact | Joakim Arwidson |
| Correspondent | Joakim Arwidson Hermes Medical Solutions AB Skeppsbron 44 Stockholm, SE 11130 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-28 |
| Decision Date | 2017-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859873006035 | K163687 | 000 |