Cleared Special

K041953 - VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART
(FDA 510(k) Clearance)

K041953 · Conmedcorp · Neurology

Aug 2004

Decision

20d

Days

Class 2

Risk

K041953 is an FDA 510(k) clearance for the VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART. This device is classified as a Electrode, Cutaneous (Class II — Special Controls, product code GXY).

Submitted by Conmedcorp (Utica, US). The FDA issued a Cleared decision on August 9, 2004, 20 days after receiving the submission on July 20, 2004.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number	K041953 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 20, 2004
Decision Date	August 09, 2004
Days to Decision	20 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Statement