Cleared Special

NORODYN 8000 SEMG SYSTEM, ND-8000

K992439 · Myotronics-Noromed, Inc. · Neurology

Aug 1999

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K992439 is an FDA 510(k) clearance for the NORODYN 8000 SEMG SYSTEM, ND-8000, a Device, Biofeedback (Class II — Special Controls, product code HCC), submitted by Myotronics-Noromed, Inc. (Tukwila, US). The FDA issued a Cleared decision on August 13, 1999, 22 days after receiving the submission on July 22, 1999. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5050.

Submission Details

510(k) Number	K992439 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 22, 1999
Decision Date	August 13, 1999
Days to Decision	22 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF