Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EMMa Electronic Monitoring Management

K-Number: K153477 · 2016-05-25

ApplicantVitasystems GmbH
Decision Date2016-05-25
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMMa Electronic Monitoring Management is a medical device manufactured by Vitasystems GmbH. It received FDA 510(k) clearance on 2016-05-25 under approval number K153477. 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 EMMa Electronic Monitoring Management?

EMMa Electronic Monitoring Management is a medical device that received FDA 510(k) clearance on 2016-05-25. It is manufactured by Vitasystems GmbH. The 510(k) number is K153477.

When was EMMa Electronic Monitoring Management approved by the FDA?

EMMa Electronic Monitoring Management received FDA 510(k) clearance on 2016-05-25, under approval number K153477.

What company makes EMMa Electronic Monitoring Management?

EMMa Electronic Monitoring Management is manufactured by Vitasystems GmbH.

What is the FDA product code for EMMa Electronic Monitoring Management?

The FDA product code for EMMa Electronic Monitoring Management is DSI.

Related Clinical Trials

NCT07615972 Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis NOT_YET_RECRUITING NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING NCT07124247 Implementation of the MOX Activity Monitor in Hospitalized Geriatric Rehabilitation COMPLETED NCT06466161 Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients RECRUITING NCT07592481 Connected Blood Pressure Monitoring in Patients With Hematologic Malignancies Initiating Covalent BTK Inhibitors NOT_YET_RECRUITING NCT06750549 Mobile Application for Patient Engagement and Physician-Directed Remote Management of Heart Failure COMPLETED

Related PubMed Literature

PMID: 42144441 A workflow utilizing general-purpose large language models for efficient structuring and data mining of bone scintigraphy narratives. Scientific reports (2026) PMID: 41970523 Large language models in healthcare quality management: a European perspective on process automation and compliance. Frontiers in digital health (2026) PMID: 41693672 Continuous Glucose Monitoring in Diabetes Care in Saudi Arabia: Addressing Performance Standards and Regulatory Gaps-Literature Review and Consensus Report. Journal of diabetes science and technology (2026) PMID: 41395509 The Challenges of Vascular Implants: Regulatory Strategies and Biological Responses. Small science (2025)

Related Devices (Code: DSI)

K153473Braemar Telemetry Patch SystemBraemar Manufacturing, LLC K152701Matrix Mini ECG MonitorGlobal Instrumentation, LLC K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation K151835Vital Signs Patch SystemLifewatch Technologies , Ltd. K151269ECG Mini System Continuous ECG Monitor and Arrhythmia DetectorLifewatch Technologies , Ltd. K173969Medicalgorithmics Unified Cardiac Rehabilitation SystemMedicalgorithmics 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.

↑