FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Fetal Doppler
K Number: K212084
·
Decision Nov 3, 2021
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
59
Applicant Total
2
Review Days
124
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Basic Information
- Device Name
- Fetal Doppler
- K Number
- K212084
- 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 Mericonn Technology Co., Ltd.
- Date Received
- July 2, 2021
- Decision Date
- November 3, 2021
- 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.
Fetal Doppler U8-25, U9-25
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Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)
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Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
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Fetal Doppler
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Shenzhen Mericonn Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K212300 | Pulse Oximeter | Feb 25, 2022 | Substantially Equivalent |