A.L.A.R.M. (Adjust. Leg & Ankle Repositioning Mech

FDA 510(k) K872525 · M.C. Johnson Co., Inc.

Substantially Equivalent

510(k) numberK872525

Submission

Device name
A.L.A.R.M. (Adjust. Leg & Ankle Repositioning Mech
Applicant
M.C. Johnson Co., Inc.
Leominster, MA, US
Received
June 25, 1987
Decision date
February 22, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KPR – System, X-Ray, Stationary
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1680
Specialty
Radiology

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Questions and answers

When was A.L.A.R.M. (Adjust. Leg & Ankle Repositioning Mech cleared by the FDA?

A.L.A.R.M. (Adjust. Leg & Ankle Repositioning Mech (K872525) received a 510(k) decision of Substantially Equivalent on February 22, 1988, 242 days after the submission was received.

What is the product code of K872525?

The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.