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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 the device name listed in this FDA 510(k) record. The listed applicant is Lifewatch Technologies , Ltd.. It received FDA 510(k) clearance on 2016-02-05 under 510(k) 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. The listed applicant is Lifewatch Technologies , Ltd.. The 510(k) number is K151835.

When did Vital Signs Patch System receive FDA 510(k) clearance?

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

Who is the listed applicant for Vital Signs Patch System?

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

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

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

Related Clinical Trials

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.

NCT06657183ECM and Monitoring w/ Alio Smart Patch in Cancer Pts Receiving ChemotherapyCOMPLETEDNCT07552805An Evaluation of Multisense® to Ensure a Safe Return Home Following High-risk Gastrointestinal Surgery, Compared With Standard Care.RECRUITINGNCT07624669A First in Human Study Investigating the Safety of an Unloaded and Loaded (With a Tetanus-containing Vaccine Booster) Microneedle Patch in Healthy AdultsNOT_YET_RECRUITINGNCT07729891Real-time Evaluation and Continuous Observation of Vital Signs for Enhanced Recovery: a Study for the Early Identification of Complications in the Surgical Ward Following Surgery in Patients Not Eligible for Intensive Care Admission.RECRUITING

Other records listing Lifewatch Technologies , Ltd. as applicant

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.

K151269ECG Mini System Continuous ECG Monitor and Arrhythmia Detector

Related Devices (Code: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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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