K251221
- 510(k) number
- K251221
- Device name
- Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)
- Applicant
- Abbott CA · US
- Product code
- MXD — Recorder, Event, Implantable Cardiac, (With Arrhythm
- Decision date
- 2025-09-17
- Date received
- 2025-04-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K251221.pdf
Official FDA record: K251221
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.