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510(k) K101960

Device
SONOTRAX SERIES ULTRASONIC POCKET DOPPLER
Applicant
EDAN INSTRUMENTS, INC.
510(k) number
K101960
Product code
HEP  
Decision
Substantially Equivalent (SESE)
Decision date
2010-08-10
Date received
2010-07-12
Regulation
884.2660
Classification name
Monitor, Blood-flow, Ultrasonic
Medical specialty
Obstetrics/Gynecology
Review panel
Radiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
YUE QIUHONG
Address
3/F-B, Nanshan Medical Equipment Park, Nanhai Rd. 1019 Shenzhen CN 518067 518067

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HEP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K023082BABYCAREBionet Company, Ltd.2003-03-03
K920353ULTRACELL INSTRUMENT WIPEUltracell Medical Technologies, Inc.1992-09-15
K910462POCKET DOP 3Imex Medical Systems, Inc.1991-06-24

Legacy Summary#

summary

FDA Review#

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