The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Vantage, For Adac Gamma Cameras.
Device ID | K943596 |
510k Number | K943596 |
Device Name: | VANTAGE, FOR ADAC GAMMA CAMERAS |
Classification | System, Tomography, Computed, Emission |
Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
Contact | Richard Zablocki |
Correspondent | Richard Zablocki 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 | 1994-07-25 |
Decision Date | 1995-04-26 |