FDA 510(k)

SureTouch Mobile Pressure Mapping System

K-Number: K181672 · 2019-06-28

Decision Date2019-06-28

Product CodeNKA

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

SureTouch Mobile Pressure Mapping System is the device name listed in this FDA 510(k) record. The listed applicant is Sure, Inc.. It received FDA 510(k) clearance on 2019-06-28 under 510(k) number K181672. The device is classified under product code NKA. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SureTouch Mobile Pressure Mapping System?

SureTouch Mobile Pressure Mapping System is a medical device that received FDA 510(k) clearance on 2019-06-28. The listed applicant is Sure, Inc.. The 510(k) number is K181672.

When did SureTouch Mobile Pressure Mapping System receive FDA 510(k) clearance?

SureTouch Mobile Pressure Mapping System received FDA 510(k) clearance on 2019-06-28, under 510(k) number K181672.

Who is the listed applicant for SureTouch Mobile Pressure Mapping System?

The FDA 510(k) record lists Sure, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SureTouch Mobile Pressure Mapping System?

The FDA product code for SureTouch Mobile Pressure Mapping System is NKA.

Related Devices (Code: NKA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190575iBreastExamUe Lifesciences, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.