TRANSAMERICA ELECTRODE— 510(k) K961749

Name: FDA 510(k) clearance K961749
Creator: U.S. Food and Drug Administration
Published: 1996-06-21

Substantially Equivalent

Transamerica Medical Systems

FDA 510(k) clearance K961749 for TRANSAMERICA ELECTRODE, Substantially Equivalent on 1996-06-21. Applicant: Transamerica Medical Systems. Device class: 2.

Clearance details

Applicant: Transamerica Medical Systems
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1996-03-25
Decision date: 1996-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Hadley, MA, US

Download summary PDF View on FDA.gov ↗

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