TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES— 510(k) K973442

Name: FDA 510(k) clearance K973442
Creator: U.S. Food and Drug Administration
Published: 1997-11-20

Substantially Equivalent

Medelec, Inc. D.B.A. Teca Corp.

FDA 510(k) clearance K973442 for TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES, Substantially Equivalent on 1997-11-20. Applicant: Medelec, Inc. D.B.A. Teca Corp.. Device class: 2.

Clearance details

Applicant: Medelec, Inc. D.B.A. Teca Corp.
Product code: Code IKT
Device class: Class 2
Regulation: 21 CFR 890.1385
Advisory panel: Physical Medicine
Date received: 1997-09-11
Decision date: 1997-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasantville, NY, US

Download summary PDF View on FDA.gov ↗

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