K243146
- 510(k) number
- K243146
- Device name
- iCare APP
- Applicant
- Ihealth Labs, Inc. CA · US
- Product code
- MWI — Monitor, Physiological, Patient (Without Arrhythmia
- Decision date
- 2025-02-03
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K243146.pdf
Official FDA record: K243146
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.