SLE EMG ELECTRODES AND ACCESSORIES— 510(k) K981004

Name: FDA 510(k) clearance K981004
Creator: U.S. Food and Drug Administration
Published: 1998-10-21

Substantially Equivalent

Specialized Laboratory Equipment, Ltd.

FDA 510(k) clearance K981004 for SLE EMG ELECTRODES AND ACCESSORIES, Substantially Equivalent on 1998-10-21. Applicant: Specialized Laboratory Equipment, Ltd.. Device class: 2.

Clearance details

Applicant: Specialized Laboratory Equipment, Ltd.
Product code: Code IKT
Device class: Class 2
Regulation: 21 CFR 890.1385
Advisory panel: Physical Medicine
Date received: 1998-03-18
Decision date: 1998-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chico, CA, US

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