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 |