Cleared Traditional

K041924 - HAUSTED POWERTRAN SERIES STRETCHER (FDA 510(k) Clearance)

Sep 2004
Decision
55d
Days
Class 2
Risk

K041924 is an FDA 510(k) clearance for the HAUSTED POWERTRAN SERIES STRETCHER. This device is classified as a Stretcher, Wheeled, Powered (Class II - Special Controls, product code INK).

Submitted by STERIS Corporation (Montgomery, US). The FDA issued a Cleared decision on September 9, 2004, 55 days after receiving the submission on July 16, 2004.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3690.

Submission Details

510(k) Number K041924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2004
Decision Date September 09, 2004
Days to Decision 55 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code INK — Stretcher, Wheeled, Powered
Device Class Class II - Special Controls
CFR Regulation 21 CFR 890.3690