K230472
- 510(k) number
- K230472
- Device name
- Sonopuls 190
- Applicant
- Enraf-Nonius, B.V. NL
- Product code
- IMI — Ultrasonic Diathermy For Use In Applying Therapeutic
- Decision date
- 2023-10-24
- Date received
- 2023-02-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K230472.pdf
Official FDA record: K230472
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.