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

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

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
LHX Trousers, Anti-Shock

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (LHX), ordered by most recent decision date.

View all

Other Clearances by Vinyl Technology, Inc.

K Number Device Name
K874052 INFLATABLE HALF LEG SPLINT
K874050 INFLATABLE FOOT & ANKLE SPLINT
K874053 INFLATABLE FULL ARM SPLINT
K874051 INFLATABLE FULL LEG SPLINT