510(k) K243146

Device
iCare APP
Applicant
Ihealth Labs, Inc.
510(k) number
K243146
Product code
MWI
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-03
Date received
2024-09-30
Regulation
870.2300
Classification name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Tianyang Liu
Address
880 W Maude Ave., Sunnyvale CA US 94085 94085

FDA Registration Numbers

Source Documents

510(k) summary PDF

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