The following data is part of a premarket notification filed by Cmsi with the FDA for Tomographic Programs.
Device ID | K790169 |
510k Number | K790169 |
Device Name: | TOMOGRAPHIC PROGRAMS |
Classification | System, Tomography, Computed, Emission |
Applicant | CMSI 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KPS |
CFR Regulation Number | 892.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-23 |
Decision Date | 1979-02-15 |