MEDISANA DIGITAL TENS— 510(k) K994265

Substantially Equivalent

Fuji Dynamics Limited

FDA 510(k) clearance K994265 for MEDISANA DIGITAL TENS, Substantially Equivalent on 2000-07-06. Applicant: Fuji Dynamics Limited. Device class: 2.

Clearance details

Applicant: Fuji Dynamics Limited
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1999-12-17
Decision date: 2000-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kowloon, HK

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.