FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Ultrasonic Fetal Doppler
K Number: K233823
·
Decision Jun 28, 2024
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
59
Applicant Total
7
Review Days
210
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Basic Information
- Device Name
- Ultrasonic Fetal Doppler
- K Number
- K233823
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2660
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Shenzhen Jamr Technology Co., Ltd.
- Date Received
- December 1, 2023
- Decision Date
- June 28, 2024
- 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
Fetal Doppler
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Shenzhen Jamr Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K253570 | Blood Pressure Monitor (W06LT) | May 20, 2026 | Substantially Equivalent |
| K251331 | Blood Pressure Monitor (B73, BE23T) | Oct 27, 2025 | Substantially Equivalent |
| K233146 | Blood Pressure Monitor | Mar 19, 2024 | Substantially Equivalent |
| K230409 | Wrist Type Blood Pressure Monitor (W05,W1101L) | Aug 25, 2023 | Substantially Equivalent |
| K220886 | Upper Arm Type Blood Pressure Monitor | Jul 27, 2022 | Substantially Equivalent |
| K200437 | Blood Pressure Monitor | Jun 25, 2020 | Substantially Equivalent |