Cleared Traditional

K042889 - DYNAMOMETER - MODEL FCE AND MODEL MSC
(FDA 510(k) Clearance)

K042889 · Ametek · Neurology

Nov 2004

Decision

28d

Days

Class 2

Risk

K042889 is an FDA 510(k) clearance for the DYNAMOMETER - MODEL FCE AND MODEL MSC. This device is classified as a Dynamometer, Ac-powered (Class II — Special Controls, product code LBB).

Submitted by Ametek (Largo, US). The FDA issued a Cleared decision on November 16, 2004, 28 days after receiving the submission on October 19, 2004.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 888.1240.

Submission Details

510(k) Number	K042889 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 19, 2004
Decision Date	November 16, 2004
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF