| Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
|---|
| 510(k) Number |
K243115 |
|---|
| Device Name |
Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) |
|---|
| Applicant |
| Shenzhen Urion Technology Co., Ltd. |
| Floor 4-6th Of Bldg. D, Jiale Science & Technology Indust |
| Rial Zone, #3, Chuang Wei Rd., Heshuikou Community, Mati |
|
Shenzhen,
CN
518106
|
|
| Applicant Contact |
Janice Ou |
| Correspondent |
| Shenzhen Urion Technology Co., Ltd. |
| Floor 4-6th Of Bldg. D, Jiale Science & Technology Indust |
| Rial Zone, #3, Chuang Wei Rd., Heshuikou Community, Mati |
|
Shenzhen,
CN
518106
|
|
| Correspondent Contact |
Janice Ou |
| Regulation Number | 870.1130 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 09/30/2024 |
|---|
| Decision Date | 02/21/2025 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Cardiovascular
|
|---|
| 510k Review Panel |
Cardiovascular
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|
|
|
