Cleared Traditional

K981730 - DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002
(FDA 510(k) Clearance)

K981730 · Nk Biotechnical Corp. · Neurology

Jul 1998

Decision

63d

Days

Class 2

Risk

K981730 is an FDA 510(k) clearance for the DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002. This device is classified as a Dynamometer, Ac-powered (Class II — Special Controls, product code LBB).

Submitted by Nk Biotechnical Corp. (Minneapolis, US). The FDA issued a Cleared decision on July 17, 1998, 63 days after receiving the submission on May 15, 1998.

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

Submission Details

510(k) Number	K981730 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 15, 1998
Decision Date	July 17, 1998
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Statement