FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Blood Pressure Monitor
K Number: K233146
·
Decision Mar 19, 2024
Classifications
1
FEI Numbers
420
Registration Numbers
420
Same Product Code
1186
Applicant Total
4
Review Days
174
Basic Information
- Device Name
- Blood Pressure Monitor
- K Number
- K233146
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Shenzhen Jamr Technology Co., Ltd.
- Date Received
- September 27, 2023
- Decision Date
- March 19, 2024
- Product Code
- DXN
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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