The following data is part of a premarket notification filed by Ge Medical Systems F.i. Haifa with the FDA for Discovery Model Nm/ct 670.
| Device ID | K093514 |
| 510k Number | K093514 |
| Device Name: | DISCOVERY MODEL NM/CT 670 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE MEDICAL SYSTEMS F.I. HAIFA 4 HAYOZMA ST. Tirat Hacarmel, IL 30200 |
| Contact | Eli Werner |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-11-13 |
| Decision Date | 2009-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682146401 | K093514 | 000 |
| 00195278788269 | K093514 | 000 |
| 00840682121187 | K093514 | 000 |
| 00840682121194 | K093514 | 000 |
| 00840682123747 | K093514 | 000 |
| 00840682123754 | K093514 | 000 |
| 00840682123877 | K093514 | 000 |
| 00840682124393 | K093514 | 000 |
| 00840682139359 | K093514 | 000 |
| 00840682139373 | K093514 | 000 |
| 00840682139403 | K093514 | 000 |
| 00840682140836 | K093514 | 000 |
| 00840682145459 | K093514 | 000 |
| 00840682145947 | K093514 | 000 |
| 00840682154338 | K093514 | 000 |
| 00195278794772 | K093514 | 000 |