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510(k) K181672

SureTouch Mobile Pressure Mapping System by Sure, Inc. — Product Code NKA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 28, 2019
Date Received: June 25, 2018
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Documentation, Breast Lesion
Device Class: Class II
Regulation Number: 884.2990
Review Panel: OB
Submission Type

A Breast lesion documentation device is a device for recording and documenting palpable breast lesions detected during a clinical breast exam.