K161700

Substantially Equivalent

SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters

Applicant: Sterilmed, Inc.
Product code: OWQ
Advisory panel: Cardiovascular
Date received: 2016-06-20
Decision date: 2016-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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