Cleared Traditional

IVC SYSTEM

K040317 · Mark H. Friedman · Physical Medicine

May 2004

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K040317 is an FDA 510(k) clearance for the IVC SYSTEM, a Pack, Hot Or Cold, Water Circulating (Class II — Special Controls, product code ILO), submitted by Mark H. Friedman (Scarsdale, US). The FDA issued a Cleared decision on May 7, 2004, 88 days after receiving the submission on February 9, 2004. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5720.

Submission Details

510(k) Number	K040317 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 09, 2004
Decision Date	May 07, 2004
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF