K233313
- 510(k) number
- K233313
- Device name
- Keikku Electronic stethoscope
- Applicant
- Lapsi Health Holding B.V. NL
- Product code
- DQD — Stethoscope, Electronic
- Decision date
- 2024-04-10
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K233313.pdf
Official FDA record: K233313
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.