K231104
- 510(k) number
- K231104
- Device name
- ABPMpro
- Applicant
- Somnomedics GmbH DE
- Product code
- DSH — Recorder, Magnetic Tape, Medical
- Decision date
- 2023-11-27
- Date received
- 2023-04-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K231104.pdf
Official FDA record: K231104
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.