FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS
K Number: K953870
·
Decision Oct 31, 1995
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
475
Review Days
75
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Basic Information
- Device Name
- ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS
- K Number
- K953870
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5400
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Vascular
- Date Received
- August 17, 1995
- Decision Date
- October 31, 1995
- Product Code
- GKN
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GKN | Timer, Clot, Automated | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GKN), ordered by most recent decision date.
MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER
FDA 510(k)
FDA Class 2
·Hematology
MIL CM-II COAGULATION MACHINE
FDA 510(k)
FDA Class 2
·Hematology
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