Ivc System

FDA 510(k) K040317 · Mark H. Friedman

Substantially Equivalent

510(k) numberK040317

Submission

Device name
Ivc System
Applicant
Mark H. Friedman
Scarsdale, NY, US
Received
February 9, 2004
Decision date
May 7, 2004
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 Ivc System cleared by the FDA?

Ivc System (K040317) received a 510(k) decision of Substantially Equivalent on May 7, 2004, 88 days after the submission was received.

What is the product code of K040317?

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