CADENCE DOPPLER ULTRASOUND SYSTEM

Monitor, Ultrasonic, Fetal

MEDASONICS, INC.

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

Pre-market Notification Details

Device IDK991441
510k NumberK991441
Device Name:CADENCE DOPPLER ULTRASOUND SYSTEM
ClassificationMonitor, Ultrasonic, Fetal
Applicant MEDASONICS, INC. 9712 S. ALTAMONT DR. Sandy,  UT  84092
ContactWilliam E Mckay
CorrespondentWilliam E Mckay
MEDASONICS, INC. 9712 S. ALTAMONT DR. Sandy,  UT  84092
Product CodeKNG  
CFR Regulation Number884.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-26
Decision Date1999-12-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00888937019858 K991441 000
00888937011340 K991441 000
00888937011333 K991441 000

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