FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNICUFF
K Number: K812639
·
Decision Oct 2, 1981
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
4
Review Days
16
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Basic Information
- Device Name
- UNICUFF
- K Number
- K812639
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2890
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Frontier Products
- Date Received
- September 16, 1981
- Decision Date
- October 2, 1981
- Product Code
- DXP
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXP | Transducer, Vessel Occlusion | FDA class 2 | Cardiovascular |
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