Cleared Traditional

EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000

K050524 · Marda Medical, Inc. · Physical Medicine

Sep 2005

Decision

196d

Days

Class 1

Risk

About This 510(k) Submission

K050524 is an FDA 510(k) clearance for the EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000, a Unit, Heating, Powered (Class I — General Controls, product code IRQ), submitted by Marda Medical, Inc. (Jensen Beach, US). The FDA issued a Cleared decision on September 14, 2005, 196 days after receiving the submission on March 2, 2005. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5950.

Submission Details

510(k) Number	K050524 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 02, 2005
Decision Date	September 14, 2005
Days to Decision	196 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF