MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER
FDA 510(k) clearance K940426 · decided 1994-09-20
Clearance details
- K-number
- K940426
- Device name
- MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER
- Applicant
- Medtronic Hemotec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-01-31
- Decision date
- 1994-09-20
- Days to decision
- 232 days
- Clearance type
- Traditional
- Product code
- GKN
- Device class
- 2
- Regulation number
- 864.5400
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Englewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS (K953870) | Medtronic Vascular | 1995-10-31 |
| MIL CM-II COAGULATION MACHINE (K913320) | Medical Innovations Corp. | 1992-06-16 |
Recalls involving this device
No recalls on record reference this clearance.