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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 a medical device manufactured by Cardiac Insight, Inc.. It received FDA 510(k) clearance on 2017-03-24 under approval 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. It is manufactured by Cardiac Insight, Inc.. The 510(k) number is K162503.

When was Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software approved by the FDA?

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

What company makes Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software?

Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software is manufactured by Cardiac Insight, Inc..

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 Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT07608614 Sleep and Performance RECRUITING NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 40845310 Should Digital Interventions for HIV Self-Testing Be Regulated with World Health Organization Prequalification? JMIR mHealth and uHealth (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: DSH)

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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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