FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
DOPPLER FETAL HEARTBEAT RATE DETECTOR
K Number: K090510
·
Decision Apr 29, 2010
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
58
Applicant Total
1
Review Days
427
Basic Information
- Device Name
- DOPPLER FETAL HEARTBEAT RATE DETECTOR
- K Number
- K090510
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2660
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SHENZHEN BESTMAN INSTRUMENT CO., LTD.
- Date Received
- February 26, 2009
- Decision Date
- April 29, 2010
- Product Code
- KNG
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- RA
- Third Party
- Y
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 |
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