510(k) K033043
- Device
- MODIFICATION TO HL168
- Applicant
- HEALTH & LIFE CO., LTD.
- 510(k) number
- K033043
- Product code
- DXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-10-10
- Date received
- 2003-09-29
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL HUNG
- Address
- 9f, #186, Jian Yi Rd. Chung Ho City, Taipei, Hsien TW 235 235
FDA Registration Numbers#
- 3003587684
- 8022257
- 3013689228
- 3003832357
- 3022147580
- 2183646
- 9615583
- 3003074886
- 3037007069
- 1832894
- 3014466900
- 1000379039
- 3007048291
- 1036863
- 3011654863
- 3012528160
- 3003764019
- 3033482477
- 3008717264
- 3017491419
- 3010082909
- 3017887928
- 3004871905
- 3031789039
- 3011200896
- 3005783425
- 3006808382
- 3003622639
- 3006793151
- 3027510187
- 3013500228
- 3014579161
- 3027344406
- 3013543897
- 3015489159
- 3013445220
- 3007184699
- 1422443
- 3010381606
- 3009560891
- 3004987887
- 3008780388
- 3020848330
- 3013729860
- 3007703436
- 3009327812
- 3015188281
- 3011792045
- 3005798905
- 3003500271
- 3004128050
- 3032916632
- 3009690509
- 3005877899
- 3005737664
- 3017953405
- 3007407626
- 3003193933
- 3004835896
- 3007499349
- 1423537
- 3013679558
- 3017858797
- 3032013079
- 3012725363
- 1054421
- 3006169981
- 3004009431
- 1218950
- 3005941719
- 3004906872
- 3009673645
- 1316463
- 9610105
- 3014166838
- 3009499478
- 3013896610
- 3012104670
- 3003829675
- 3008573045
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DXN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
| 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 |
| K253982 | Korotkoff sound blood pressure monitor | Beijing Hanvon Health Technology Co., Ltd. | 2026-04-21 |
| K260276 | Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro | Shenzhen AOJ Medical Technology Co., Ltd. | 2026-04-01 |
| K254225 | Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL) | Shenzhen HanHan Technology Co., Ltd. | 2026-04-01 |
| K260273 | Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) | Shenzhen Urion Technology Co., Ltd. | 2026-03-26 |
| K252779 | YUWELL® Electronic Blood Pressure Monitor (YE630CR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-03-05 |
| K253228 | YUWELL® Electronic Blood Pressure Monitor (YE650AR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-02-23 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases