FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Fetal Doppler U8-25, U9-25
K Number: K252669
·
Decision Jan 8, 2026
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
59
Applicant Total
1
Review Days
136
Basic Information
- Device Name
- Fetal Doppler U8-25, U9-25
- K Number
- K252669
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2660
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zhongshan Xiaolan Town Senlan Electronic Factory
- Date Received
- August 25, 2025
- Decision Date
- January 8, 2026
- Product Code
- KNG
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KNG | Monitor, Ultrasonic, Fetal | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNG), ordered by most recent decision date.
Doppler FHR Detector (BF-500D+, BF-560)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Ultrasonic Fetal Doppler
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Fetal Doppler
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Fetal Doppler
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology