Cleared Traditional

K162412 - Hoggan Scientific? microFET2?
(FDA 510(k) Clearance)

K162412 · Hoggan Scientific, LLC · Neurology

Mar 2017

Decision

192d

Days

Class 2

Risk

K162412 is an FDA 510(k) clearance for the Hoggan Scientific? microFET2?. This device is classified as a Dynamometer, Ac-powered (Class II — Special Controls, product code LBB).

Submitted by Hoggan Scientific, LLC (Salt Lake City, US). The FDA issued a Cleared decision on March 9, 2017, 192 days after receiving the submission on August 29, 2016.

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

Submission Details

510(k) Number	K162412 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 29, 2016
Decision Date	March 09, 2017
Days to Decision	192 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF