FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Fetal Doppler, Model FD88
K Number: K182710
·
Decision Mar 1, 2019
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
59
Applicant Total
1
Review Days
155
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Basic Information
- Device Name
- Fetal Doppler, Model FD88
- K Number
- K182710
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2660
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzzhen Luckcome Technology Inc., Ltd.
- Date Received
- September 27, 2018
- Decision Date
- March 1, 2019
- 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 |
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