EPIQ 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 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK132304
510k NumberK132304
Device Name:EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant PHILIPS ULTRASOUND, INC. 22100 BOTHELL EVERETT HWY. Bothell,  WA  98021
ContactJessica Stenberg
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 Received2013-07-24
Decision Date2013-08-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838067837 K132304 000
00884838047693 K132304 000
00884838056244 K132304 000
00884838056251 K132304 000
00884838061422 K132304 000
00884838061446 K132304 000
00884838061507 K132304 000
00884838061545 K132304 000
00884838061552 K132304 000
00884838061576 K132304 000
00884838061590 K132304 000
00884838061606 K132304 000
00884838061644 K132304 000
00884838061651 K132304 000
00884838047686 K132304 000

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