Cleared Traditional

K022309 - STRYKER POWERED WHEELED STRETCHER (FDA 510(k) Clearance)

Nov 2002
Decision
115d
Days
Class 2
Risk

K022309 is an FDA 510(k) clearance for the STRYKER POWERED WHEELED STRETCHER. This device is classified as a Stretcher, Wheeled, Powered (Class II - Special Controls, product code INK).

Submitted by Stryker Corp. (Washington, US). The FDA issued a Cleared decision on November 8, 2002, 115 days after receiving the submission on July 16, 2002.

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

Submission Details

510(k) Number K022309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2002
Decision Date November 08, 2002
Days to Decision 115 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