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FDA 510(k)

Vital Signs Patch System

K-Number: K151835 · 2016-02-05

ApplicantLifewatch Technologies , Ltd.
Decision Date2016-02-05
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vital Signs Patch System is a medical device manufactured by Lifewatch Technologies , Ltd.. It received FDA 510(k) clearance on 2016-02-05 under approval number K151835. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vital Signs Patch System?

Vital Signs Patch System is a medical device that received FDA 510(k) clearance on 2016-02-05. It is manufactured by Lifewatch Technologies , Ltd.. The 510(k) number is K151835.

When was Vital Signs Patch System approved by the FDA?

Vital Signs Patch System received FDA 510(k) clearance on 2016-02-05, under approval number K151835.

What company makes Vital Signs Patch System?

Vital Signs Patch System is manufactured by Lifewatch Technologies , Ltd..

What is the FDA product code for Vital Signs Patch System?

The FDA product code for Vital Signs Patch System is DSI.

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 40775863 Use of the Learning Health System to Redesign and Implement a Clinical Decision Support System for Antimicrobial Stewardship. Studies in health technology and informatics (2025) PMID: 40085833 The Measurement of Vital Signs in Pediatric Patients by Lifelight Software in Comparison to the Standard of Care: Protocol for the VISION-Junior Observational Study. JMIR research protocols (2025)

Other Devices by Lifewatch Technologies , Ltd.

K151269ECG Mini System Continuous ECG Monitor and Arrhythmia Detector

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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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