FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFLATE-A-CUFF #7014
K Number: K910903
·
Decision May 8, 1991
Classifications
1
FEI Numbers
172
Registration Numbers
172
Same Product Code
197
Applicant Total
5
Review Days
64
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Basic Information
- Device Name
- INFLATE-A-CUFF #7014
- K Number
- K910903
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1120
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Pa Medical Corp.
- Date Received
- March 5, 1991
- Decision Date
- May 8, 1991
- 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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Other Clearances by Pa Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K871449 | ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG | Jun 17, 1987 | Substantially Equivalent |
| K860084 | PRESSURE INFUSOR #1900 | Mar 18, 1986 | Substantially Equivalent |
| K854595 | P.A. MEDICAL VAGINAL IRRIGATION SET #1130 | Jan 13, 1986 | Substantially Equivalent |
| K853309 | P.A. ENTERAL FEEDING BAG 1100 | Aug 27, 1985 | Substantially Equivalent |