Cleared Traditional

K052309 - DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006
(FDA 510(k) Clearance)

K052309 · Saehan Corp. · Neurology

Sep 2005

Decision

34d

Days

Class 2

Risk

K052309 is an FDA 510(k) clearance for the DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006. This device is classified as a Dynamometer, Ac-powered (Class II — Special Controls, product code LBB).

Submitted by Saehan Corp. (Flintville, US). The FDA issued a Cleared decision on September 27, 2005, 34 days after receiving the submission on August 24, 2005.

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

Submission Details

510(k) Number	K052309 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 24, 2005
Decision Date	September 27, 2005
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF