K252589
- 510(k) number
- K252589
- Device name
- Corvair Monza
- Applicant
- AliveCor, Inc. CA · US
- Product code
- MHX — Monitor, Physiological, Patient(With Arrhythmia Dete
- Decision date
- 2026-01-09
- Date received
- 2025-08-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K252589.pdf
Official FDA record: K252589
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.