K170474

Substantially Equivalent

Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter

Applicant: Innovative Health, LLC
Product code: OWQ
Advisory panel: Cardiovascular
Date received: 2017-02-16
Decision date: 2017-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

Download summary PDF View on FDA.gov ↗

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