MIL CM-II COAGULATION MACHINE
FDA 510(k) clearance K913320 · decided 1992-06-16
Clearance details
- K-number
- K913320
- Device name
- MIL CM-II COAGULATION MACHINE
- Applicant
- Medical Innovations Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-07-25
- Decision date
- 1992-06-16
- Days to decision
- 327 days
- Clearance type
- Traditional
- Product code
- GKN
- Device class
- 2
- Regulation number
- 864.5400
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Kowloon, Hong Kong, HK
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medical Innovations Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER (K940426) | Medtronic Hemotec, Inc. | 1994-09-20 |
Recalls involving this device
No recalls on record reference this clearance.