TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERS
FDA 510(k) clearance K874774 · decided 1988-02-08
Clearance details
- K-number
- K874774
- Device name
- TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERS
- Applicant
- Vinyl Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-11-19
- Decision date
- 1988-02-08
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- LHX
- Device class
- 2
- Regulation number
- 870.5800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- So. El Monte, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GLADIATOR ANTISHOCK PANTS (K953763) | Jobst Institute, Inc. | 1995-11-28 |
| BP TRAUMA AIR PANTS (K841605) | Bp Medical Systems, Inc. | 1984-07-06 |
| ZEE LIFE SUPPORT AIR PANTS (K812564) | Zee Medical Products Co., Inc. | 1981-10-23 |
Recalls involving this device
No recalls on record reference this clearance.