SMARTWAVE IF 2000— 510(k) K003631

Substantially Equivalent

Newwave Medical, LLC

FDA 510(k) clearance K003631 for SMARTWAVE IF 2000, Substantially Equivalent on 2001-08-10. Applicant: Newwave Medical, LLC. Device class: 2.

Clearance details

Applicant: Newwave Medical, LLC
Product code: Code LIH
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2000-11-24
Decision date: 2001-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, 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.