DeviceClearance

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.

Clearance details

Applicant
Newwave Medical, LLC
Product code
Code LIH
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Plano, TX, US
Download summary PDFView on FDA.gov ↗

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