Cleared Traditional

K942948 - STRYKER POWERED STRETCHER (FDA 510(k) Clearance)

Jan 1995
Decision
215d
Days
Class 2
Risk

K942948 is an FDA 510(k) clearance for the STRYKER POWERED STRETCHER. This device is classified as a Stretcher, Wheeled (Class II - Special Controls, product code FPO).

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on January 24, 1995, 215 days after receiving the submission on June 23, 1994.

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

Submission Details

510(k) Number K942948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1994
Decision Date January 24, 1995
Days to Decision 215 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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