510(k) K171062
- Device
- BP5S Wireless Blood Pressure Monitor
- Applicant
- Andon Health Co., Ltd.
- 510(k) number
- K171062
- Product code
- DXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-08-01
- Date received
- 2017-04-10
- Regulation
- 870.1130
- Classification name
- System, Measurement, Blood-pressure, Non-invasive
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Liu Yi
- Address
- # 3 Jin Ping St.,Ya An Rd. Nankai District Tianjin CN 300190 300190
FDA Registration Numbers#
- 3013557562
- 3032013079
- 3042579404
- 3013545943
- 3038598497
- 3008716327
- 3016719957
- 3017424877
- 3043025312
- 3007048291
- 3008729547
- 3011200334
- 8043510
- 3008820594
- 3011420269
- 2221819
- 3005735282
- 3016674095
- 2183646
- 3007663004
- 3043513123
- 3017953405
- 3017896172
- 3014982318
- 3016445583
- 3010262192
- 3013319763
- 3004128050
- 3009327812
- 3010536822
- 9617594
- 1927197
- 3021282523
- 9611045
- 3015328411
- 1319390
- 3006733253
- 1423537
- 3003993690
- 3021247088
- 9680548
- 3027135885
- 3023272766
- 8022257
- 3006636961
- 3001373226
- 3005798905
- 3003500271
- 3012840029
- 3016707048
- 3003622639
- 1220908
- 3019470217
- 3005783425
- 3018008670
- 9610105
- 3007413079
- 3021611414
- 3026585241
- 2648727
- 3006543075
- 9617543
- 3009889471
- 3004906872
- 3006169981
- 3013517171
- 3011200896
- 3012104670
- 3044174020
- 3004835896
- 3017491419
- 3014449259
- 3004832480
- 3006087789
- 3016640651
- 3007154442
- 3003741676
- 3009077524
- 3010880718
Source Documents#
Other 510(k) Records For Product Code DXN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252501 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L) | Joytech Healthcare Co. , Ltd. | 2026-04-28 |
| K260260 | Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569) | Honsun (Nantong) Co., Ltd. | 2026-04-28 |
| K253982 | Korotkoff sound blood pressure monitor | Beijing Hanvon Health Technology Co., Ltd. | 2026-04-21 |
Legacy Summary#
summary
FDA Review#
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