K230184
- 510(k) number
- K230184
- Device name
- Holter ECG and ABP System
- Applicant
- Edan Instruments, Inc. CN
- Product code
- DSH — Recorder, Magnetic Tape, Medical
- Decision date
- 2023-09-25
- Date received
- 2023-01-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K230184.pdf
Official FDA record: K230184
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.