510(k) K173028
- Device
- BPro BT Ambulatory Blood Pressure Monitoring System With BProSoft BT PC Software
- Applicant
- HealthSTATS International Pte Ltd
- 510(k) number
- K173028
- Product code
- DXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-06-21
- Date received
- 2017-09-28
- Regulation
- 870.1130
- Classification name
- System, Measurement, Blood-pressure, Non-invasive
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ngak Hwee Chua
- Address
- 3 Ang Mo Kio St. 62 #08-25/26, Link@Amk Singapore SG 536199 536199
FDA Registration Numbers#
- 3010262192
- 3027344406
- 3004128050
- 3016931915
- 3006769302
- 3015489159
- 3020460367
- 1319390
- 3003294644
- 3009001657
- 3010838917
- 3013920399
- 3010381606
- 3010390468
- 3004009431
- 3004101980
- 3031259044
- 3005737664
- 1423537
- 3017075369
- 1832894
- 3004906872
- 1000379039
- 3011654863
- 3006537699
- 3021635975
- 3020115
- 3016826509
- 3006087789
- 3009901017
- 3008365372
- 3001373226
- 3005798905
- 3038620598
- 3003263092
- 3001149827
- 3006950086
- 9610816
- 3021186226
- 9680215
- 3033530347
- 3006113127
- 3004832480
- 9710654
- 3017303999
- 9710602
- 3007384659
- 3013053058
- 1066444
- 3016170326
- 3003591740
- 8020616
- 3034405508
- 3015236197
- 3008264255
- 3003687189
- 3015181391
- 3020160672
- 3011191255
- 8020605
- 3027135885
- 3007420856
- 3012536737
- 3013426279
- 3024512705
- 3037724692
- 3038761440
- 3015109923
- 3012494290
- 3003703880
- 3008975047
- 3017825461
- 9617476
- 3004022358
- 3017894657
- 3003971136
- 3013557562
- 3008787503
- 3014449259
Source Documents#
Other 510(k) Records For Product Code DXN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K253152 | BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) | Biozen, LLC | 2026-05-06 |
Legacy Summary#
summary
FDA Review#
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