The following data is part of a premarket notification filed by Critical Care Systems, Inc. with the FDA for Record Keeping/data Management System.
| Device ID | K865035 |
| 510k Number | K865035 |
| Device Name: | RECORD KEEPING/DATA MANAGEMENT SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | CRITICAL CARE SYSTEMS, INC. 5000 HOLLYWOOD BLVD. Hollywood, FL 33021 |
| Contact | Wendy Marx |
| Correspondent | Wendy Marx CRITICAL CARE SYSTEMS, INC. 5000 HOLLYWOOD BLVD. Hollywood, FL 33021 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-23 |
| Decision Date | 1987-05-11 |