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FDA 510(k)

SureTouch Mobile Pressure Mapping System

K-Number: K181672 · 2019-06-28

ApplicantSure, Inc.
Decision Date2019-06-28
Product CodeNKA
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SureTouch Mobile Pressure Mapping System is a medical device manufactured by Sure, Inc.. It received FDA 510(k) clearance on 2019-06-28 under approval 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. It is manufactured by Sure, Inc.. The 510(k) number is K181672.

When was SureTouch Mobile Pressure Mapping System approved by the FDA?

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

What company makes SureTouch Mobile Pressure Mapping System?

SureTouch Mobile Pressure Mapping System is manufactured by Sure, Inc..

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 Clinical Trials

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Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

Related Devices (Code: NKA)

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.

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