Cleared Traditional

K874774 - TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERS
(FDA 510(k) Clearance)

K874774 · Vinyl Technology, Inc. · Anesthesiology
Feb 1988
Decision
81d
Days
Class 2
Risk

K874774 is an FDA 510(k) clearance for the TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERS, a Trousers, Anti-shock (Class II — Special Controls, product code LHX), submitted by Vinyl Technology, Inc. (So. El Monte, US). The FDA issued a Cleared decision on February 8, 1988, 81 days after receiving the submission on November 19, 1987. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K874774 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 1987
Decision Date February 08, 1988
Days to Decision 81 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

Product Code LHX — Trousers, Anti-shock
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5800