Cleared Traditional

PAIN VISION, MODEL PS-2100

K072882 · Osachi Co., Ltd. · Neurology

Jan 2009

Decision

457d

Days

Class 1

Risk

About This 510(k) Submission

K072882 is an FDA 510(k) clearance for the PAIN VISION, MODEL PS-2100, a Device, Vibration Threshold Measurement (Class I — General Controls, product code LLN), submitted by Osachi Co., Ltd. (Las Vegas, US). The FDA issued a Cleared decision on January 8, 2009, 457 days after receiving the submission on October 9, 2007. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1200.

Submission Details

510(k) Number	K072882 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 09, 2007
Decision Date	January 08, 2009
Days to Decision	457 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF