The following data is part of a premarket notification filed by Sitco, Inc. with the FDA for Nuquest Nuclear Medicine Computer.
Device ID | K953255 |
510k Number | K953255 |
Device Name: | NUQUEST NUCLEAR MEDICINE COMPUTER |
Classification | System, Tomography, Computed, Emission |
Applicant | SITCO, INC. 25663 HILLVIEW CT. Mundelein, IL 60060 |
Contact | Robert H Mccarthy |
Correspondent | Robert H Mccarthy SITCO, INC. 25663 HILLVIEW CT. Mundelein, IL 60060 |
Product Code | KPS |
CFR Regulation Number | 892.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-07-12 |
Decision Date | 1995-10-24 |