REFA, PHYSIOLOGICAL AMPLIFIER— 510(k) K060374

Name: FDA 510(k) clearance K060374
Creator: U.S. Food and Drug Administration
Published: 2006-05-30

Substantially Equivalent

Tms International BV

FDA 510(k) clearance K060374 for REFA, PHYSIOLOGICAL AMPLIFIER, Substantially Equivalent on 2006-05-30. Applicant: Tms International BV. Device class: 2.

Clearance details

Applicant: Tms International BV
Product code: Code GWL
Device class: Class 2
Regulation: 21 CFR 882.1835
Advisory panel: Neurology
Date received: 2006-02-13
Decision date: 2006-05-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Evergreen, CO, US

Download summary PDF View on FDA.gov ↗

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