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))
Shenzhen Urion Technology Co., Ltd. · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Shenzhen
- Advisory committee description
- Cardiovascular
- Address 1
- Floor 4-6th Of Bldg. D, Jiale Science & Technology Indust
- Address 2
- Rial Zone, #3, Chuang Wei Rd., Heshuikou Community, Mati
- Statement or summary
- Summary
- Product code
- DXN
- Zip code
- 518106
- Applicant
- Shenzhen Urion Technology Co., Ltd.
- Decision date
- 2025-02-21
- Decision code
- SESE
- Country code
- CN
- Advisory committee
- CV
- Contact
- Janice Ou
- K number
- K243115
- Date received
- 2024-09-30
- Review advisory committee
- CV
- Postal code
- 518106
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- 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))
- Harmonized identifiers (openFDA)
- Device name
- System, Measurement, Blood-Pressure, Non-Invasive
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1130
- Device class
- 2
- Registration number
- 2648045, 3015236197, 3008729547, 3008167616, 3009456923, 3003589956, 3012302888, 3017896172, 3003193933, 3013445220, 3010390468, 3016674095, 3043226252, 3033589330, 3014541700, 3009156722, 3024512705, 3016170326, 3003622639, 3043513123, 3004727093, 3013896610, 3032948391, 3013679558, 3009690509, 9710654, 2434008, 3031789039, 9610816, 3038620598, 2025816, 3005737664, 3003971136, 3018008670, 3013561145, 3008483389, 3010405299, 3008011951, 3038761440, 3007603826 +387 more
- FEI number
- 2648045, 3015236197, 3008729547, 3008167616, 3009456923, 3003589956, 3012302888, 1000292048, 3017896172, 3003193933, 3013445220, 3010390468, 3016674095, 3043226252, 3033589330, 3014541700, 3009156722, 3024512705, 3016170326, 3003622639, 3043513123, 3004727093, 3013896610, 3032948391, 3013679558, 3002806476, 3009690509, 2434008, 3031789039, 3038620598, 2025816, 3005737664, 3003971136, 3018008670, 3013561145, 3008483389, 3010405299, 3008011951, 3038761440, 3007603826 +387 more