K231150
- 510(k) number
- K231150
- Device name
- Cardio P1
- Applicant
- Bionet Co., Ltd. KR
- Product code
- DPS — Electrocardiograph
- Decision date
- 2023-11-09
- Date received
- 2023-04-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K231150.pdf
Official FDA record: K231150
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.