The following data is part of a premarket notification filed by Hemotech, Inc. with the FDA for Hepcon Hms With Body Surface Area Calculation.
| Device ID | K911240 |
| 510k Number | K911240 |
| Device Name: | HEPCON HMS WITH BODY SURFACE AREA CALCULATION |
| Classification | Analyzer, Heparin, Automated |
| Applicant | HEMOTECH, INC. 7103 S. REVERE PKWY. Englewood, CO 80112 |
| Contact | Robert F Baugh |
| Correspondent | Robert F Baugh HEMOTECH, INC. 7103 S. REVERE PKWY. Englewood, CO 80112 |
| Product Code | JOX |
| CFR Regulation Number | 864.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-21 |
| Decision Date | 1991-07-17 |