The following data is part of a premarket notification filed by Adac Laboratories with the FDA for C-equal(ceders-emory Quantitive Analysis).
Device ID | K932745 |
510k Number | K932745 |
Device Name: | C-EQUAL(CEDERS-EMORY QUANTITIVE ANALYSIS) |
Classification | System, Tomography, Computed, Emission |
Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
Contact | Paul Vicha |
Correspondent | Paul Vicha 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 | 1993-06-08 |
Decision Date | 1993-08-05 |