Spire Health Remote Patient Monitoring System

System, Network And Communication, Physiological Monitors

Spire, Inc. D/b/a Spire Health

The following data is part of a premarket notification filed by Spire, Inc. D/b/a Spire Health with the FDA for Spire Health Remote Patient Monitoring System.

Pre-market Notification Details

Device IDK192952
510k NumberK192952
Device Name:Spire Health Remote Patient Monitoring System
ClassificationSystem, Network And Communication, Physiological Monitors
Applicant Spire, Inc. D/b/a Spire Health 2030 Harrison St San Francisco,  CA  94110
ContactJoanne Hollenbach
CorrespondentJared Seehafer
Enzyme Corporation 360 Langton St, Ste 100 San Francisco,  CA  94103
Product CodeMSX  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-21
Decision Date2020-06-05

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