K243603
- 510(k) number
- K243603
- Device name
- AeviceMD
- Applicant
- Aevice Health Pte. , Ltd. SG
- Product code
- DSH — Recorder, Magnetic Tape, Medical
- Decision date
- 2025-05-05
- Date received
- 2024-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243603.pdf
Official FDA record: K243603
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.