The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Inspect/prospect.
Device ID | K952564 |
510k Number | K952564 |
Device Name: | INSPECT/PROSPECT |
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 | 1995-06-02 |
Decision Date | 1995-11-22 |