510(k) K244000
- Device
- Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+);
- Applicant
- Shenzhen AOJ Medical Technology Co., Ltd.
- 510(k) number
- K244000
- Product code
- DXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-04-30
- Date received
- 2024-12-26
- Regulation
- 870.1130
- Classification name
- System, Measurement, Blood-Pressure, Non-Invasive
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jack Wang
- Address
- Rm. 301&4f, Block A, Bldg. A,Ingfa Intelligent Manafacturing Park Xiaweiyuan,Gushu Community, Xixiang St. Bao'An District Shenzhen CN 518126 518126
FDA Registration Numbers#
- 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
- 3019470217
- 3011065399
- 3009901017
- 1126271
- 3015181391
- 3007384659
- 3037007069
- 3017896172
- 3026815676
- 3007603826
- 3006769302
- 8020616
- 3017303999
- 1066427
- 9611031
- 1220908
- 3022147580
- 3005798905
- 3003864328
- 3029987970
- 3005569927
- 3006082230
- 3022946813
- 3027135885
- 3001034529
- 3001744144
- 3010421104
- 3012528160
- 3015188281
- 3037724692
- 3012696053
- 3003500271
- 3017207990
- 3007413079
- 3012421607
- 3008293988
- 3003800159
- 8022077
- 3013053058
- 3004022358
Source Documents#
Other 510(k) Records For Product Code DXN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260470 | Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206) | Shenzhen Brav Electronic Technologies Co., Ltd. | 2026-10-01 |
| K261929 | Upper Arm Blood pressure monitor (BP7155D) | OMRON Healthcare, Inc. | 2026-09-10 |
| K254000 | Happy Health Blood Pressure Monitor | Happy Health, Inc. | 2026-09-03 |
| K262658 | Automatic Digital Blood Pressure monitor (LD-526) | Honsun (Nantong) Co., Ltd. | 2026-08-31 |
| K261394 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus) | JOYTECH Healthcare Co., Ltd. | 2026-08-26 |
| K253425 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P) | Joytech Healthcare Co. , Ltd. | 2026-08-13 |
| K261061 | BP Go (BPP-855) | Wellvii, Inc. | 2026-08-13 |
| K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) | Microlife Corporation | 2026-07-23 |
| K261136 | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) | Guangzhou Daxin Health Technology Co., Ltd. | 2026-07-23 |
| K253126 | Wrist Blood Pressure Monitor (XW-05) | Shenzhen Ziqing Medical Equipment Co., Ltd. | 2026-06-18 |
| K260693 | VicorderCS (VCS-SYS-1100) | 80 Beats Medical GmbH | 2026-06-16 |
| K253059 | Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) | Tournicare Pty, Ltd. | 2026-06-15 |
| K253124 | Upper arm electronic blood pressure monitor (XB-01) | Shenzhen Ziqing Medical Equipment Co., Ltd. | 2026-06-03 |
| K253570 | Blood Pressure Monitor (W06LT) | Shenzhen Jamr Technology Co., Ltd. | 2026-05-20 |
| K254048 | Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) | Shenzhen Urion Technology Co., Ltd. | 2026-05-14 |