VIVATRAK— 510(k) K101109

Substantially Equivalent

Wireless Medcare, LLC

FDA 510(k) clearance K101109 for VIVATRAK, Substantially Equivalent on 2010-07-15. Applicant: Wireless Medcare, LLC. Device class: 1.

Clearance details

Applicant: Wireless Medcare, LLC
Product code: Code KMI
Device class: Class 1
Regulation: 21 CFR 880.2400
Advisory panel: General Hospital
Date received: 2010-04-20
Decision date: 2010-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

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