The following data is part of a premarket notification filed by Computerized Medical Systems, Inc. with the FDA for Cms Record And Verify System.
Device ID | K882484 |
510k Number | K882484 |
Device Name: | CMS RECORD AND VERIFY SYSTEM |
Classification | System, Therapeutic, X-ray |
Applicant | COMPUTERIZED MEDICAL SYSTEMS, INC. 56 WORTHINGTON DR. Maryland Heights, MO 63043 -3806 |
Contact | Melvin Mccollum |
Correspondent | Melvin Mccollum COMPUTERIZED MEDICAL SYSTEMS, INC. 56 WORTHINGTON DR. Maryland Heights, MO 63043 -3806 |
Product Code | JAD |
CFR Regulation Number | 892.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-15 |
Decision Date | 1988-12-21 |