EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)— 510(k) K982754

Name: FDA 510(k) clearance K982754
Creator: U.S. Food and Drug Administration
Published: 1999-01-08

Substantially Equivalent

A.Stein - Regulatory Affairs Consulting

FDA 510(k) clearance K982754 for EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC), Substantially Equivalent on 1999-01-08. Applicant: A.Stein - Regulatory Affairs Consulting. Device class: 1.

Clearance details

Applicant: A.Stein - Regulatory Affairs Consulting
Product code: Code FWF
Device class: Class 1
Regulation: 21 CFR 878.4160
Advisory panel: General, Plastic Surgery
Date received: 1998-08-06
Decision date: 1999-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ginot Shomron 44853, IL

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