510(k) K042273
- Device
- MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY
- Applicant
- HEALTH HERO NETWORK, INC.
- 510(k) number
- K042273
- Product code
- DXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-08-31
- Date received
- 2004-08-23
- 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
- GEOFFREY J CLAPP
- Address
- 2570 W. El Camino Real Suite 111 Mountain View CA US 94040 94040
FDA Registration Numbers#
- 3037007069
- 3034603279
- 3013826848
- 3038761440
- 3003622639
- 3005737664
- 8030978
- 3006082230
- 3007740533
- 3016867013
- 3007413079
- 2648045
- 2022435
- 3007154442
- 3009831876
- 2221819
- 3042156936
- 3003832357
- 3011353843
- 3013545943
- 3010880718
- 3005536872
- 1651104
- 3026567235
- 3020460367
- 3014466900
- 3008780388
- 3003829675
- 3044174020
- 3008164770
- 3017207990
- 1220649
- 3045076243
- 1832894
- 3017896172
- 3022028624
- 3004415095
- 3008729547
- 1000379039
- 3027510187
- 3010968402
- 3013689228
- 3016075711
- 3007353620
- 3015188281
- 3015309643
- 3007305624
- 3012312061
- 3004594267
- 8020616
- 1927197
- 3028107593
- 9616164
- 3006087789
- 3014774380
- 3024790242
- 3006733253
- 3011912849
- 3023412068
- 3010262192
- 3011200896
- 3033589330
- 3012421607
- 1126271
- 1423537
- 3006648320
- 3014015501
- 9615817
- 3004987887
- 3014449259
- 2434008
- 3026753375
- 3009499478
- 3013517171
- 3006169981
- 3018783526
- 3013596024
- 3009690509
- 3006792041
- 3011191255
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 |
Legacy Summary#
summary
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