Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo
Shenzhen AOJ Medical Technology Co., Ltd. · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Shenzhen
- Advisory committee description
- Cardiovascular
- Address 1
- Rm. 301&4f, Block A, Bldg. A, Jingfa Intelligent Manufac
- Address 2
- Cturing Park Xiaweiyuan, Gushu Community, Xixiang St.,
- Statement or summary
- Summary
- Product code
- DXN
- Zip code
- 518126
- Applicant
- Shenzhen AOJ Medical Technology Co., Ltd.
- Decision date
- 2025-05-02
- Decision code
- SESE
- Country code
- CN
- Advisory committee
- CV
- Contact
- Jack Wang
- K number
- K250161
- Date received
- 2025-01-21
- Review advisory committee
- CV
- Postal code
- 518126
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Device name
Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo
- Harmonized identifiers (openFDA)
- Device name
- System, Measurement, Blood-Pressure, Non-Invasive
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1130
- Device class
- 2
- Registration number
- 3004009431, 3027510187, 8030476, 3015876, 3013679558, 3043047278, 3013783488, 9617543, 1054421, 3033530347, 3007499349, 3001570235, 1216677, 8010061, 9680548, 3010703925, 3028107593, 3008395508, 3009673645, 3005536872, 3044174020, 3035111606, 1422443, 3005290115, 3014601569, 3007184699, 3010698831, 3003829675, 3011654863, 3003703880, 8030978, 3010419931, 3016445583, 3009690509, 3022425463, 3006543075, 3026585241, 3015542362, 3009327812, 3042579404 +390 more
- FEI number
- 3004009431, 3027510187, 3015876, 3013679558, 3043047278, 3013783488, 3033530347, 3001570235, 1216677, 3010703925, 3028107593, 3008395508, 3009673645, 3003335291, 1000300598, 3005536872, 3002807167, 3044174020, 3003171455, 3035111606, 3005290115, 3014601569, 3007184699, 3000215024, 3010698831, 3003829675, 3011654863, 3005176386, 3003757840, 3003703880, 3000957797, 3010419931, 3016445583, 3009690509, 3022425463, 3006543075, 3026585241, 3015542362, 3009327812, 1000263641 +390 more