GKN — Timer, Clot, Automated Class II
FDA product code GKN covers "Timer, Clot, Automated", a Class II medical device regulated under 21 CFR 864.5400. Submissions are reviewed by the Hematology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GKN
- Device Class
- Class II
- Regulation Number
- 864.5400
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K953870 | medtronic vascular | ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS | October 31, 1995 |
| K940426 | medtronic hemotec | MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER | September 20, 1994 |
| K913320 | medical innovations | MIL CM-II COAGULATION MACHINE | June 16, 1992 |