ShockPulse-SE Lithotripsy System

Lithotriptor, Ultrasonic

Cybersonics, Inc.

The following data is part of a premarket notification filed by Cybersonics, Inc. with the FDA for Shockpulse-se Lithotripsy System.

Pre-market Notification Details

Device IDK171024
510k NumberK171024
Device Name:ShockPulse-SE Lithotripsy System
ClassificationLithotriptor, Ultrasonic
Applicant Cybersonics, Inc. Knowledge Park, 5340 Fryling Road, Suite 101 Erie,  PA  16510
ContactSamradni Patil
CorrespondentSamradni Patil
Cybersonics, Inc. Knowledge Park, 5340 Fryling Road, Suite 101 Erie,  PA  16510
Product CodeFEO  
CFR Regulation Number876.4480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-05
Decision Date2017-08-21
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.