Regulatory filing

K234070 (us_fda)

FDA 510(k) K234070 for Stelo Glucose Biosensor System (Mar 2024). OTC continuous glucose monitor.

fda 510k · cleared · decided 2024-03-05

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Revision history: /regulatory-filings/stelo-glucose-fda-510k-k234070/history
Data documentation: /data
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Key facts

Jurisdiction: us_fda
Filing type: fda 510k
Status: cleared
Filing number: K234070
Filing date: 2024-03-05
Decision date: 2024-03-05
Verification posture: verified

Applicant

Covered models (1)

Stelo

Sources (1)

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234070

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Identity

7d42e48e-632c-456e-abcf-88352f50d3ab