The following data is part of a premarket notification filed by Haemoscope Corp. with the FDA for Thrombelastograph Coagulation Analyzer 3000s.
| Device ID | K954437 |
| 510k Number | K954437 |
| Device Name: | THROMBELASTOGRAPH COAGULATION ANALYZER 3000S |
| Classification | Instrument, Coagulation, Automated |
| Applicant | HAEMOSCOPE CORP. 7855 GROSS POINT RD. SUITE G4 Skokie, IL 60077 |
| Contact | Charmaine Sutton |
| Correspondent | Charmaine Sutton HAEMOSCOPE CORP. 7855 GROSS POINT RD. SUITE G4 Skokie, IL 60077 |
| Product Code | GKP |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-22 |
| Decision Date | 1996-01-30 |