Model 792 Converge, Model 793 Vision 2000

FDA 510(k) K945431 · Hausted, Inc.

Substantially Equivalent

510(k) numberK945431

Submission

Device name
Model 792 Converge, Model 793 Vision 2000
Applicant
Hausted, Inc.
Medina, OH, US
Received
August 15, 1994
Decision date
January 25, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FPO – Stretcher, Wheeled
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6910
Specialty
General Hospital

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Questions and answers

When was Model 792 Converge, Model 793 Vision 2000 cleared by the FDA?

Model 792 Converge, Model 793 Vision 2000 (K945431) received a 510(k) decision of Substantially Equivalent on January 25, 1995, 163 days after the submission was received.

What is the product code of K945431?

The FDA product code is FPO – Stretcher, Wheeled, a Class II (moderate risk) device regulated under 21 CFR 880.6910.