Cleared Traditional

K922808 - HILL-ROM VIA STRETCHER (P1300 - P1303) (FDA 510(k) Clearance)

Mar 1993
Decision
294d
Days
Class 2
Risk

K922808 is an FDA 510(k) clearance for the HILL-ROM VIA STRETCHER (P1300 - P1303). This device is classified as a Stretcher, Wheeled (Class II - Special Controls, product code FPO).

Submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on March 31, 1993, 294 days after receiving the submission on June 10, 1992.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6910.

Submission Details

510(k) Number K922808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1992
Decision Date March 31, 1993
Days to Decision 294 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPO — Stretcher, Wheeled
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.6910