Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)
Guangdong Xinyu Electronic and Technology Co., Ltd. · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Zhongshan
- Advisory committee description
- Cardiovascular
- Address 1
- Number 42, Cuicheng Rd., Cuiheng New District
- Statement or summary
- Summary
- Product code
- DXN
- Zip code
- 528400
- Applicant
- Guangdong Xinyu Electronic and Technology Co., Ltd.
- Decision date
- 2025-02-11
- Decision code
- SESE
- Country code
- CN
- Device name
- Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)
- Advisory committee
- CV
- Contact
- Rita Long
- K number
- K241634
- Date received
- 2024-06-06
- Review advisory committee
- CV
- Postal code
- 528400
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- 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