The following data is part of a premarket notification filed by Zycare with the FDA for Coagcare Anticoagulation Management System.
| Device ID | K050821 |
| 510k Number | K050821 |
| Device Name: | COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM |
| Classification | Instrument, Coagulation |
| Applicant | ZYCARE 3804 SWEETEN CREEK RD. Chapel Hill, NC 27514 |
| Contact | Steve D Holdaway |
| Correspondent | Steve D Holdaway ZYCARE 3804 SWEETEN CREEK RD. Chapel Hill, NC 27514 |
| Product Code | KQG |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-31 |
| Decision Date | 2005-08-16 |
| Summary: | summary |