K232670
- 510(k) number
- K232670
- Device name
- HiCardi+ H100
- Applicant
- MEZOO Co., Ltd. KR
- Product code
- DSH — Recorder, Magnetic Tape, Medical
- Decision date
- 2024-09-20
- Date received
- 2023-09-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K232670.pdf
Official FDA record: K232670
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.