The following data is part of a premarket notification filed by Hemotec, Inc. with the FDA for Hemotec Hepcon Hms Coagulation System & Access..
Device ID | K894317 |
510k Number | K894317 |
Device Name: | HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. |
Classification | Analyzer, Heparin, Automated |
Applicant | HEMOTEC, INC. 7103 SOUTH REVERE PKWY. Englewood, CO 80112 |
Contact | Taylor, M.s. |
Correspondent | Taylor, M.s. HEMOTEC, INC. 7103 SOUTH 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 | 1989-07-14 |
Decision Date | 1989-09-05 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00613994909404 | K894317 | 000 |
20613994697169 | K894317 | 000 |
00763000014797 | K894317 | 000 |
00763000014780 | K894317 | 000 |
00763000014773 | K894317 | 000 |
00763000014766 | K894317 | 000 |
00763000014759 | K894317 | 000 |
00643169713253 | K894317 | 000 |
00643169713222 | K894317 | 000 |
00643169713215 | K894317 | 000 |
00643169713208 | K894317 | 000 |
00643169713192 | K894317 | 000 |
00643169713185 | K894317 | 000 |
00643169713178 | K894317 | 000 |
00643169713161 | K894317 | 000 |
00643169713154 | K894317 | 000 |
20613994697176 | K894317 | 000 |
20613994697183 | K894317 | 000 |
20613994697190 | K894317 | 000 |
00681490512084 | K894317 | 000 |
00673978698793 | K894317 | 000 |
00721902433719 | K894317 | 000 |
00885074092904 | K894317 | 000 |
20613994923329 | K894317 | 000 |
20613994923312 | K894317 | 000 |
20613994923305 | K894317 | 000 |
20613994923299 | K894317 | 000 |
20613994923282 | K894317 | 000 |
20613994923275 | K894317 | 000 |
20613994697244 | K894317 | 000 |
20613994697237 | K894317 | 000 |
20613994697220 | K894317 | 000 |
20613994697213 | K894317 | 000 |
20613994697206 | K894317 | 000 |
00643169713147 | K894317 | 000 |