The following data is part of a premarket notification filed by Computerized Medical Systems, Inc. with the FDA for Cms Record And Verify.
Device ID | K921108 |
510k Number | K921108 |
Device Name: | CMS RECORD AND VERIFY |
Classification | System, Simulation, Radiation Therapy |
Applicant | COMPUTERIZED MEDICAL SYSTEMS, INC. 56 WORTHINGTON DR. Maryland Heights, MO 63043 -3806 |
Contact | Kim Ort |
Correspondent | Kim Ort COMPUTERIZED MEDICAL SYSTEMS, INC. 56 WORTHINGTON DR. Maryland Heights, MO 63043 -3806 |
Product Code | KPQ |
CFR Regulation Number | 892.5840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-03-09 |
Decision Date | 1992-11-02 |