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FDA 510(k)

Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software

K-Number: K162503 · 2017-03-24

ApplicantCardiac Insight, Inc.
Decision Date2017-03-24
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Insight, Inc.. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K162503. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software?

Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Cardiac Insight, Inc.. The 510(k) number is K162503.

When did Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software receive FDA 510(k) clearance?

Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software received FDA 510(k) clearance on 2017-03-24, under 510(k) number K162503.

Who is the listed applicant for Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software?

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

What is the FDA product code for Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software?

The FDA product code for Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software is DSH.

Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

Official Source

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

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