IU22 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 Iu22 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK130499
510k NumberK130499
Device Name:IU22 DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant PHILIPS ULTRASOUND, INC. 22100 BOTHELL EVERETT HWY. Bothell,  WA  98021 -8431
ContactJessica Stenberg
CorrespondentJessica Stenberg
PHILIPS ULTRASOUND, INC. 22100 BOTHELL EVERETT HWY. Bothell,  WA  98021 -8431
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-02-26
Decision Date2013-06-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838067981 K130499 000
00884838061729 K130499 000
00884838061743 K130499 000
00884838061774 K130499 000
00884838061781 K130499 000
00884838064577 K130499 000
00884838064584 K130499 000
00884838064614 K130499 000
00884838067493 K130499 000
00884838067509 K130499 000
00884838067523 K130499 000
00884838067547 K130499 000
00884838067561 K130499 000
00884838067615 K130499 000
00884838067639 K130499 000
00884838067684 K130499 000
00884838067967 K130499 000
00884838025172 K130499 000

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