Hepcon HMS with Body Surface Area Calculation
FDA 510(k) K911240 · Hemotech, Inc.
510(k) numberK911240
Submission
- Device name
- Hepcon HMS with Body Surface Area Calculation
- Applicant
- Hemotech, Inc.
Englewood, CO, US - Received
- March 21, 1991
- Decision date
- July 17, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JOX – Analyzer, Heparin, Automated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5680
- Specialty
- Hematology
Other 510(k)s with product code JOX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K111339 | Hemostasis Managment System Plus (Hms-Plus)JOX · Special | Medtronic, Inc. | 06/08/2011SE |
| K102953 | Heparin Dose Response CartridgeJOX · Special | Medtronic, Inc. | 11/04/2010SE |
| K101271 | Hemostasis Management System Plus (HMS Plus ), Model 305 XXJOX · Special | Medtronic, Inc. | 10/13/2010SE |
| K051040 | Heparin Dose Response Controls, Model 306-20 PorJOX · Special | Medtronic Perfusion Systems | 05/24/2005SE |
| K043080 | Heparin Dose Response Controls, Model 306-20 PorJOX · Special | Medtronic Vascular | 12/03/2004SE |
| K042070 | Heparin Dose Response Cartridge, Model 304-20JOX · Special | Medtronic Vascular | 10/01/2004SE |
| K993519 | Rapidpoint Accent, Model 2000, Rapidpoint Coag Heparin Titration Test, Rapidpoint Coag…JOX · Traditional | Cardiovascular Diagnostics, Inc. | 01/14/2000SE |
| K922031 | HMS Purple and Black Heparin Cartridges & ControlJOX · Traditional | Medtronic Hemotec, Inc. | 07/21/1992SE |
| K894317 | Hemotec Hepcon HMS Coagulation System & Access.JOX · Traditional | Hemotec, Inc. | 09/05/1989SE |
| K854377 | Hemotec CV Whole Blood Coagulation ControlsJOX · Traditional | Hemotec, Inc. | 12/04/1985SE |
Questions and answers
When was Hepcon HMS with Body Surface Area Calculation cleared by the FDA?
Hepcon HMS with Body Surface Area Calculation (K911240) received a 510(k) decision of Substantially Equivalent on July 17, 1991, 118 days after the submission was received.
What is the product code of K911240?
The FDA product code is JOX – Analyzer, Heparin, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5680.