K261074
- 510(k) number
- K261074
- Device name
- BIOMONITOR IV (471155)
- Applicant
- Biotronik, Inc. OR · US
- Product code
- MXD — Recorder, Event, Implantable Cardiac, (With Arrhythm
- Decision date
- 2026-05-01
- Date received
- 2026-04-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.2 MB · U.S. public domain
Also available from FDA: K261074.pdf
Official FDA record: K261074
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.