The following data is part of a premarket notification filed by Silicon Instruments Gmhb with the FDA for Handheld Gamma Finder (hgf).
| Device ID | K013751 |
| 510k Number | K013751 |
| Device Name: | HANDHELD GAMMA FINDER (HGF) |
| Classification | Probe, Uptake, Nuclear |
| Applicant | SILICON INSTRUMENTS GMHB OSTENDSTRASSE 1 Berlin, DE D-12459 |
| Contact | Thomas Goebel |
| Correspondent | Thomas Goebel SILICON INSTRUMENTS GMHB OSTENDSTRASSE 1 Berlin, DE D-12459 |
| Product Code | IZD |
| CFR Regulation Number | 892.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-13 |
| Decision Date | 2002-02-06 |
| Summary: | summary |