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510(k) K243146

iCare APP by Ihealth Labs, Inc. — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2025
Date Received
September 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Ihealth Labs, Inc.

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  • K233842 — iHealth COVID-19 Antigen Rapid Test (May 31, 2024)

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  • K233446 — AMC Health CareConsole (September 27, 2024)
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