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 |