| Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
|---|
| 510(k) Number |
K251113 |
|---|
| Device Name |
iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr |
|---|
| Applicant |
| Andon Health Co, Ltd. |
| # 3 Jin Ping St.,Ya An Rd. |
| Nankai District |
|
Tianjin,
CN
300190
|
|
| Applicant Contact |
Liu Yi |
| Correspondent |
| Andon Health Co, Ltd. |
| # 3 Jin Ping St.,Ya An Rd. |
| Nankai District |
|
Tianjin,
CN
300190
|
|
| Correspondent Contact |
Liu Yi |
| Regulation Number | 870.1130 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 04/11/2025 |
|---|
| Decision Date | 08/04/2025 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Cardiovascular
|
|---|
| 510k Review Panel |
Cardiovascular
|
|---|
| Summary |
Summary
|
| Type |
Abbreviated
|
|---|
| Clinical Trials |
NCT05551845
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|
|
|
