Cleared Traditional

NEVOSCOPE

K954943 · Nizar A. Mullani · General Hospital

Mar 1996

Decision

149d

Days

Class 1

Risk

About This 510(k) Submission

K954943 is an FDA 510(k) clearance for the NEVOSCOPE, a Device, Medical Examination, Ac Powered (Class I — General Controls, product code KZF), submitted by Nizar A. Mullani (Sugar Land, US). The FDA issued a Cleared decision on March 27, 1996, 149 days after receiving the submission on October 30, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6320.

Submission Details

510(k) Number	K954943 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 30, 1995
Decision Date	March 27, 1996
Days to Decision	149 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF