SureTouch Mobile Pressure Mapping System— 510(k) K181672

Name: FDA 510(k) clearance K181672
Creator: U.S. Food and Drug Administration
Published: 2019-06-28

Substantially Equivalent

Sure, Inc.

FDA 510(k) clearance K181672 for SureTouch Mobile Pressure Mapping System, Substantially Equivalent on 2019-06-28. Applicant: Sure, Inc.. Device class: 2.

Clearance details

Applicant: Sure, Inc.
Product code: Code NKA
Device class: Class 2
Regulation: 21 CFR 884.2990
Advisory panel: Obstetrics/Gynecology
Date received: 2018-06-25
Decision date: 2019-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palos Verdes Estates, CA, US

Download summary PDF View on FDA.gov ↗

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