FRANTZ MEDICAL ELECTRODE— 510(k) K863508

Name: FDA 510(k) clearance K863508
Creator: U.S. Food and Drug Administration
Published: 1987-02-06

Substantially Equivalent

Frantz Medical Development, Ltd.

FDA 510(k) clearance K863508 for FRANTZ MEDICAL ELECTRODE, Substantially Equivalent on 1987-02-06. Applicant: Frantz Medical Development, Ltd.. Device class: 2.

Clearance details

Applicant: Frantz Medical Development, Ltd.
Product code: Code DXR
Device class: Class 2
Regulation: 21 CFR 870.2320
Advisory panel: Cardiovascular
Date received: 1986-09-09
Decision date: 1987-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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