M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540

System, Imaging, Pulsed Doppler, Ultrasonic

PHILIPS MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for M2540 Diagnostic Ultrasound System, Model M2540.

Pre-market Notification Details

Device IDK014191
510k NumberK014191
Device Name:M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover,  MA  01810 -1099
ContactSteve Singlar
CorrespondentMark Job
TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton,  MN  55112 -1891
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2001-12-21
Decision Date2002-01-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00884838061378 K014191 000

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