The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Vantage Exspect Ii.
| Device ID | K992078 |
| 510k Number | K992078 |
| Device Name: | VANTAGE EXSPECT II |
| Classification | System, Tomography, Computed, Emission |
| Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Contact | Genine M Grant |
| Correspondent | Genine M Grant ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-18 |
| Decision Date | 1999-09-01 |
| Summary: | summary |