FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNICUFF-BLOOD PRESSURE CUFF
K Number: K831001
·
Decision Jul 28, 1983
Classifications
1
FEI Numbers
172
Registration Numbers
172
Same Product Code
197
Applicant Total
4
Review Days
121
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Basic Information
- Device Name
- UNICUFF-BLOOD PRESSURE CUFF
- K Number
- K831001
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1120
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Frontier Products
- Date Received
- March 29, 1983
- Decision Date
- July 28, 1983
- Product Code
- DXQ
- 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 |
|---|---|---|---|
| DXQ | Blood Pressure Cuff | FDA class 2 | Cardiovascular |
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