LIFEDOP MODEL 300ABI

Monitor, Ultrasonic, Nonfetal

SUMMIT DOPPLER SYSTEMS, INC.

The following data is part of a premarket notification filed by Summit Doppler Systems, Inc. with the FDA for Lifedop Model 300abi.

Pre-market Notification Details

Device IDK093393
510k NumberK093393
Device Name:LIFEDOP MODEL 300ABI
ClassificationMonitor, Ultrasonic, Nonfetal
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 CodeJAF  
CFR Regulation Number892.1540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-10-30
Decision Date2009-12-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
60888937010260 K093393 000
60888937010253 K093393 000
40612479199666 K093393 000
00888937019919 K093393 000
00888937002362 K093393 000
00888937002188 K093393 000
00888937002171 K093393 000
00888937002089 K093393 000
00888937002072 K093393 000

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