K253516
- 510(k) number
- K253516
- Device name
- Assert-IQ (DM5100)
- Applicant
- ABBOTT MEDICAL CA · US
- Product code
- MXD — Recorder, Event, Implantable Cardiac, (With Arrhythm
- Decision date
- 2025-12-18
- Date received
- 2025-11-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K253516.pdf
Official FDA record: K253516
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.