The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Discovery Nm 750b Bopsy.
| Device ID | K160933 |
| 510k Number | K160933 |
| Device Name: | Discovery NM 750b Bopsy |
| Classification | Camera, Scintillation (gamma) |
| Applicant | GE Healthcare 4 Hayozma Street Tirat Hacarmel, IL 30200 |
| Contact | Efrat Hartog-david |
| Correspondent | Efrat Hartog-david GE Healthcare 4 Hayozma Street Tirat Hacarmel, IL 30200 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-04 |
| Decision Date | 2016-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682138758 | K160933 | 000 |
| 00840682138741 | K160933 | 000 |
| 00840682138697 | K160933 | 000 |