EPIQ Series Diagnostic Ultrasound Systems

System, Imaging, Pulsed Doppler, Ultrasonic

Philips Ultrasound, Inc.

The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Epiq Series Diagnostic Ultrasound Systems.

Pre-market Notification Details

Device IDK202216
510k NumberK202216
Device Name:EPIQ Series Diagnostic Ultrasound Systems
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Philips Ultrasound, Inc. 22100 Bothell Everett Highway Bothell,  WA  98021 -8431
ContactColin S. Jacob
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
Subsequent Product CodeOBJ
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-08-06
Decision Date2020-09-02

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