FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERS
K Number: K874774
·
Decision Feb 8, 1988
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
3
Applicant Total
5
Review Days
81
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Basic Information
- Device Name
- TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERS
- K Number
- K874774
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Vinyl Technology, Inc.
- Date Received
- November 19, 1987
- Decision Date
- February 8, 1988
- Product Code
- LHX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| LHX | Trousers, Anti-Shock | FDA class 2 | Cardiovascular |
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Other Clearances by Vinyl Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K874052 | INFLATABLE HALF LEG SPLINT | Nov 23, 1987 | Substantially Equivalent |
| K874050 | INFLATABLE FOOT & ANKLE SPLINT | Nov 23, 1987 | Substantially Equivalent |
| K874053 | INFLATABLE FULL ARM SPLINT | Nov 23, 1987 | Substantially Equivalent |
| K874051 | INFLATABLE FULL LEG SPLINT | Nov 23, 1987 | Substantially Equivalent |