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FDA 510(k)

Spire Health Remote Patient Monitoring System

K-Number: K192952 · 2020-06-05

ApplicantSpire, Inc. D/B/A Spire Health
Decision Date2020-06-05
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Spire Health Remote Patient Monitoring System is a medical device manufactured by Spire, Inc. D/B/A Spire Health. It received FDA 510(k) clearance on 2020-06-05 under approval number K192952. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spire Health Remote Patient Monitoring System?

Spire Health Remote Patient Monitoring System is a medical device that received FDA 510(k) clearance on 2020-06-05. It is manufactured by Spire, Inc. D/B/A Spire Health. The 510(k) number is K192952.

When was Spire Health Remote Patient Monitoring System approved by the FDA?

Spire Health Remote Patient Monitoring System received FDA 510(k) clearance on 2020-06-05, under approval number K192952.

What company makes Spire Health Remote Patient Monitoring System?

Spire Health Remote Patient Monitoring System is manufactured by Spire, Inc. D/B/A Spire Health.

What is the FDA product code for Spire Health Remote Patient Monitoring System?

The FDA product code for Spire Health Remote Patient Monitoring System is MSX.

Related Clinical Trials

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Related PubMed Literature

PMID: 42208661 A FeAsibility items Checklist for assessing implementation characTeristics of patient reported Outcome measures in Research, Regulation and Routine clinical care (FACTOR3): development and evaluation. Clinical medicine (London, England) (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026) PMID: 41970523 Large language models in healthcare quality management: a European perspective on process automation and compliance. Frontiers in digital health (2026)

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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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