The following data is part of a premarket notification filed by Cygnus Of South Florida, Inc. with the FDA for Criticalc.
| Device ID | K860854 |
| 510k Number | K860854 |
| Device Name: | CRITICALC |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | CYGNUS OF SOUTH FLORIDA, INC. 560 N.W. 165TH RD. SUITE 309 MIAMI, FL 33169 |
| Contact | ALAN SEGAL |
| Correspondent | ALAN SEGAL CYGNUS OF SOUTH FLORIDA, INC. 560 N.W. 165TH RD. SUITE 309 MIAMI, FL 33169 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-07 |
| Decision Date | 1986-12-08 |