The following data is part of a premarket notification filed by Micromedical Industries, Ltd. with the FDA for Cms System.
| Device ID | K922528 |
| 510k Number | K922528 |
| Device Name: | CMS SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | MICROMEDICAL INDUSTRIES, LTD. 255 REVERE DR. SUITE 101 Northbrook, IL 60062 |
| Contact | Harry Platt |
| Correspondent | Harry Platt MICROMEDICAL INDUSTRIES, LTD. 255 REVERE DR. SUITE 101 Northbrook, IL 60062 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-28 |
| Decision Date | 1995-05-12 |