The following data is part of a premarket notification filed by Medtronic Hemotec, Inc. with the FDA for Medtronic Hemotec Act Ii Automated Coagulation Timer.
| Device ID | K940426 |
| 510k Number | K940426 |
| Device Name: | MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER |
| Classification | Timer, Clot, Automated |
| Applicant | MEDTRONIC HEMOTEC, INC. 7103 S. REVERE PKWY. Englewood, CO 80112 |
| Contact | Robert F Baugh |
| Correspondent | Robert F Baugh MEDTRONIC HEMOTEC, INC. 7103 S. REVERE PKWY. Englewood, CO 80112 |
| Product Code | GKN |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-31 |
| Decision Date | 1994-09-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994416551 | K940426 | 000 |
| 00613994390714 | K940426 | 000 |
| 00643169178434 | K940426 | 000 |
| 00643169178410 | K940426 | 000 |
| 00643169178380 | K940426 | 000 |
| 00721902932946 | K940426 | 000 |
| 00721902932939 | K940426 | 000 |
| 00721902793066 | K940426 | 000 |
| 00763000135478 | K940426 | 000 |