FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)
K Number: K254225
·
Decision Apr 1, 2026
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
1
Review Days
93
Basic Information
- Device Name
- Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)
- K Number
- K254225
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen HanHan Technology Co., Ltd.
- Date Received
- December 29, 2025
- Decision Date
- April 1, 2026
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXN), ordered by most recent decision date.
Wrist Blood Pressure Monitor (XW-05)
FDA 510(k)
FDA Class 2
·Cardiovascular
VicorderCS (VCS-SYS-1100)
FDA 510(k)
FDA Class 2
·Cardiovascular
Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)
FDA 510(k)
FDA Class 2
·Cardiovascular
Upper arm electronic blood pressure monitor (XB-01)
FDA 510(k)
FDA Class 2
·Cardiovascular
Blood Pressure Monitor (W06LT)
FDA 510(k)
FDA Class 2
·Cardiovascular
Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)
FDA 510(k)
FDA Class 2
·Cardiovascular