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510(k) K181672

Device
SureTouch Mobile Pressure Mappring System
Applicant
Sure Inc.
510(k) number
K181672
Product code
NKA  
Decision
Substantially Equivalent (SESE)
Decision date
2019-06-28
Date received
2018-06-25
Regulation
884.2990
Classification name
System, Documentation, Breast Lesion
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
David Ables
Address
1404 Granvia Altamira Palos Verdes Estates CA US 90274 90274

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NKA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K190575iBreastExamUe Lifesciences, Inc.2019-07-16
K142926iBreastExamUe Lifesciences, Inc.2015-04-23
DEN020001BREASTVIEW VISUAL MAPPING SYSTEMAssurance Medical2003-01-31

Legacy Summary#

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FDA Review#

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