K232893
- 510(k) number
- K232893
- Device name
- Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)
- Applicant
- Contec Medical Systems Co.,Ltd CN
- Product code
- KNG — Monitor, Ultrasonic, Fetal
- Decision date
- 2024-06-14
- Date received
- 2023-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K232893.pdf
Official FDA record: K232893
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.