The following data is part of a premarket notification filed by Adac Laboratories with the FDA for Apollo Gamma Camera System.
Device ID | K062298 |
510k Number | K062298 |
Device Name: | APOLLO GAMMA CAMERA SYSTEM |
Classification | System, Tomography, Computed, Emission |
Applicant | ADAC LABORATORIES 540 ALDER DR. Milpitas, CA 95035 |
Contact | Annie Wright |
Correspondent | Morten Simon Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
Product Code | KPS |
CFR Regulation Number | 892.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2006-08-08 |
Decision Date | 2006-08-23 |
Summary: | summary |