STN PROBE

Transducer, Ultrasonic, Diagnostic

SUMMIT DOPPLER SYSTEMS, INC.

The following data is part of a premarket notification filed by Summit Doppler Systems, Inc. with the FDA for Stn Probe.

Pre-market Notification Details

Device IDK101816
510k NumberK101816
Device Name:STN PROBE
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant SUMMIT DOPPLER SYSTEMS, INC. 4680 TABLE MOUNTAIN DR #150 Golden,  CO  80403
ContactKen Jarrell
CorrespondentKen Jarrell
SUMMIT DOPPLER SYSTEMS, INC. 4680 TABLE MOUNTAIN DR #150 Golden,  CO  80403
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-30
Decision Date2010-08-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00888937002010 K101816 000
00888937001983 K101816 000

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