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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 the device name listed in this FDA 510(k) record. The listed applicant is Spire, Inc. D/B/A Spire Health. It received FDA 510(k) clearance on 2020-06-05 under 510(k) 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. The listed applicant is Spire, Inc. D/B/A Spire Health. The 510(k) number is K192952.

When did Spire Health Remote Patient Monitoring System receive FDA 510(k) clearance?

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

Who is the listed applicant for Spire Health Remote Patient Monitoring System?

The FDA 510(k) record lists Spire, Inc. D/B/A Spire Health as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: MSX)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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