Sked Flotation System

FDA 510(k) K896179 · Skedco, Inc.

Substantially Equivalent

510(k) numberK896179

Submission

Device name
Sked Flotation System
Applicant
Skedco, Inc.
Portland, OR, US
Received
October 25, 1989
Decision date
January 11, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FPP – Stretcher, Hand-Carried
Device class
Class I (low risk)
Regulation
21 CFR 880.6900
Specialty
General Hospital

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More from Bissell Medical Products, Inc.

510(k)DeviceDecision
K896177Sked StretcherFPP · Traditional 01/11/1990SE

Questions and answers

When was Sked Flotation System cleared by the FDA?

Sked Flotation System (K896179) received a 510(k) decision of Substantially Equivalent on January 11, 1990, 78 days after the submission was received.

What is the product code of K896179?

The FDA product code is FPP – Stretcher, Hand-Carried, a Class I (low risk) device regulated under 21 CFR 880.6900.