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FDA 510(k)

Capsule Vitals Plus Patient Monitoring System

K-Number: K210204 · 2021-10-19

ApplicantCapsule Technologie Sas
Decision Date2021-10-19
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Capsule Vitals Plus Patient Monitoring System is a medical device manufactured by Capsule Technologie Sas. It received FDA 510(k) clearance on 2021-10-19 under approval number K210204. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Capsule Vitals Plus Patient Monitoring System?

Capsule Vitals Plus Patient Monitoring System is a medical device that received FDA 510(k) clearance on 2021-10-19. It is manufactured by Capsule Technologie Sas. The 510(k) number is K210204.

When was Capsule Vitals Plus Patient Monitoring System approved by the FDA?

Capsule Vitals Plus Patient Monitoring System received FDA 510(k) clearance on 2021-10-19, under approval number K210204.

What company makes Capsule Vitals Plus Patient Monitoring System?

Capsule Vitals Plus Patient Monitoring System is manufactured by Capsule Technologie Sas.

What is the FDA product code for Capsule Vitals Plus Patient Monitoring System?

The FDA product code for Capsule Vitals Plus Patient Monitoring System is MWI.

Related Clinical Trials

NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT07615972 Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41970523 Large language models in healthcare quality management: a European perspective on process automation and compliance. Frontiers in digital health (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026)

Other Devices by Capsule Technologie Sas

K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module K200856SmartLinx Vitals Plus Patient Monitoring System

Related Devices (Code: MWI)

K161909IQvitals ZoneMidmark Corporation K160718Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien K151839AMC Health VitalCaregiving SystemAmc Health K160956LD-Oxi systemLd Technology, LLC K153739MRI Patient Monitor TeslaDUOMipm Mammendorfer Institut Fur Physik Und Medizin K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation

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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