510(k) K202228
- Device
- Omron Model BP7900 Blood Pressure Monitor + EKG
- Applicant
- Omron Healthcare, Inc.
- 510(k) number
- K202228
- Product code
- DXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-04-01
- Date received
- 2020-08-07
- 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
- Renee Thornborough
- Address
- 1925 W. Field Ct. Suite 100 Lake Forest IL US 60045 60045
FDA Registration Numbers#
- 3003950102
- 3005798905
- 3012302888
- 3004727197
- 3008729899
- 3010222749
- 9680548
- 3001034529
- 1319390
- 3008780388
- 3001570235
- 3009499478
- 3013561145
- 3006169981
- 3003263092
- 3010419931
- 3003591740
- 1220908
- 8030245
- 2081040
- 3017500903
- 3037007069
- 3007184699
- 3021559257
- 1713468
- 3015328411
- 3006537699
- 3008716327
- 3031158
- 8030476
- 3021186226
- 1018233
- 3014736845
- 3004832480
- 3017887928
- 3010421104
- 3008264255
- 3006146787
- 3008507279
- 3029987970
- 2025816
- 3009831876
- 3042156936
- 2082313
- 3015542362
- 3014982318
- 3012421607
- 3020160672
- 3013826848
- 3007134734
- 3015236197
- 3013596024
- 3038613041
- 3015455735
- 8031509
- 3029871637
- 3012725363
- 3015136472
- 9611295
- 3017953405
- 3019388613
- 3022028624
- 3013053058
- 1523530
- 1218950
- 3017207990
- 3019575688
- 3001744144
- 3009001657
- 9610105
- 3008787503
- 3018940143
- 3016170326
- 3027135885
- 3021635975
- 3009155917
- 3012528160
- 3009973336
- 3011912849
Source Documents#
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 |
| 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 |
| 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 |
| 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 |
| 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