Documento fuente o registro público
FDA 510(k) K201394 — CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System
FDA 510(k) index record K201394. Device: CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System. Applicant as listed: I-Sens, Inc.. Decision date: 2021-10-05.
Fuente
"device_name": "CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System"
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Automated FDA record verification
2026-10-20
2026-10-31
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FDA 510(k) public index record K201394.
Device name: CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System. Applicant as listed: I-Sens, Inc..
Decision date: 2021-10-05. Decision wording: Substantially Equivalent.
Product code: NBW. Regulation: 21 CFR 862.1345. Medical specialty: Clinical Chemistry.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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