Crytron System

FDA 510(k) K955529 · Mark H. Friedman

Substantially Equivalent

510(k) numberK955529

Submission

Device name
Crytron System
Applicant
Mark H. Friedman
Mount Vernon, NY, US
Received
December 4, 1995
Decision date
June 10, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ILO – Pack, Hot Or Cold, Water Circulating
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5720
Specialty
Physical Medicine

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Questions and answers

When was Crytron System cleared by the FDA?

Crytron System (K955529) received a 510(k) decision of Substantially Equivalent on June 10, 1996, 189 days after the submission was received.

What is the product code of K955529?

The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.