K253088
- 510(k) number
- K253088
- Device name
- OneStim-DUO Cardiac Stimulator (MP5003-4CO)
- Applicant
- Micropace Pty, Ltd. AU
- Product code
- DQK — Computer, Diagnostic, Programmable
- Decision date
- 2026-06-12
- Date received
- 2025-09-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K253088.pdf
Official FDA record: K253088
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.