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FDA 510(k)

SmartLinx Vitals Plus Patient Monitoring System

K-Number: K183638 · 2019-04-17

ApplicantCapsule Technologie
Decision Date2019-04-17
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SmartLinx Vitals Plus Patient Monitoring System is a medical device manufactured by Capsule Technologie. It received FDA 510(k) clearance on 2019-04-17 under approval number K183638. 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 SmartLinx Vitals Plus Patient Monitoring System?

SmartLinx Vitals Plus Patient Monitoring System is a medical device that received FDA 510(k) clearance on 2019-04-17. It is manufactured by Capsule Technologie. The 510(k) number is K183638.

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

SmartLinx Vitals Plus Patient Monitoring System received FDA 510(k) clearance on 2019-04-17, under approval number K183638.

What company makes SmartLinx Vitals Plus Patient Monitoring System?

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

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

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

Related Clinical Trials

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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

K180734SmartLinx 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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