Cleared Traditional

K940130 - STRYKER MODEL 6110 EMERGENCY/POLE STRETCHER
(FDA 510(k) Clearance)

Mar 1994
Decision
66d
Days
Class 1
Risk

K940130 is an FDA 510(k) clearance for the STRYKER MODEL 6110 EMERGENCY/POLE STRETCHER. This device is classified as a Stretcher, Hand-carried (Class I - General Controls, product code FPP).

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on March 10, 1994, 66 days after receiving the submission on January 3, 1994.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6900.

Submission Details

510(k) Number K940130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1994
Decision Date March 10, 1994
Days to Decision 66 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FPP — Stretcher, Hand-carried
Device Class Class I - General Controls
CFR Regulation 21 CFR 880.6900