PHILIPS IU22 ULTRASOUND SYSTEM

System, Imaging, Pulsed Echo, Ultrasonic

PHILIPS ULTRASOUND, INC.

The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Philips Iu22 Ultrasound System.

Pre-market Notification Details

Device IDK042540
510k NumberK042540
Device Name:PHILIPS IU22 ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant PHILIPS ULTRASOUND, INC. 22100 BOTHELL EVERETT HWY. Bothell,  WA  98021
ContactLynn Harmer
Product CodeIYO  
Subsequent Product CodeITX
Subsequent Product CodeIYN
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-09-20
Decision Date2004-10-04
Summary:summary

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