The following data is part of a premarket notification filed by Mie Gmbh with the FDA for Ecat Scintron Pet.
| Device ID | K130269 |
| 510k Number | K130269 |
| Device Name: | ECAT SCINTRON PET |
| Classification | System, Tomography, Computed, Emission |
| Applicant | MIE GMBH HAUPTSTRASSE 112 Seth, DE D-23845 |
| Contact | Thomas Kuehl |
| Correspondent | Thomas Kuehl MIE GMBH HAUPTSTRASSE 112 Seth, DE D-23845 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-04 |
| Decision Date | 2013-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260484140029 | K130269 | 000 |