EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 And Affiniti 70 Diagnostic Ultrasound System

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 , Epiq 5, Epiq 7, Affiniti 30, Affiniti 50 And Affiniti 70 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK181485
510k NumberK181485
Device Name:EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 And Affiniti 70 Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Philips Ultrasound, Inc. 22100 Bothell-Everett Hwy Bothell,  WA  98021
ContactKym Rupp
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2018-06-06
Decision Date2018-07-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838086609 K181485 000

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