510(k) K233130
- Device
- Blood Pressure Monitor
- Applicant
- Guangdong Transtek Medical Electronics Co., Ltd.
- 510(k) number
- K233130
- Product code
- DXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-20
- Date received
- 2023-09-27
- 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
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Jerry Fan
- Address
- Zone A, # 105, Dongli Rd., Torch Development District Zhongshan CN 528437 528437
FDA Registration Numbers
- 3011651103
- 1066444
- 1054713
- 3016170326
- 3015109923
- 3016701404
- 3027135885
- 9680225
- 1216677
- 3030447506
- 3007353620
- 3008395508
- 3010390468
- 3006899423
- 3001034529
- 3008716327
- 1423537
- 1000379039
- 3033589330
- 3006950086
- 3003864328
- 3016826509
- 3014015501
- 3043513123
- 3012302888
- 3018940143
- 3004918630
- 3022946813
- 3006808382
- 3012540196
- 8030476
- 3030733800
- 3003703880
- 3017406171
- 1066270
- 3017896172
- 3024790242
- 3016075711
- 3021422553
- 3014630021
- 3027510187
- 3007413079
- 3008973759
- 3027256461
- 3017303999
- 3007603826
- 8010482
- 3034603279
- 3014579161
- 3015542362
- 3007048291
- 3008787503
- 3009690509
- 3008293988
- 3004485927
- 3021247088
- 9610816
- 3009889471
- 3015136472
- 8043510
- 3020848330
- 3007740533
- 3003263092
- 3011353843
- 3006636961
- 3038598497
- 3021635975
- 3017953405
- 3021186226
- 2032112
- 3023412068
- 3009901017
- 3012104670
- 3022028624
- 2030598
- 3012840029
- 3018008670
- 3011790297
- 1219324
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code DXN
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K253133 | Wrist Blood Pressure Monitor (BPM-W1VL) | Shenzhen Imdk Medical Technology Co., Ltd. | 2026-02-13 |
| K252685 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P) | Joytech Healthcare Co. , Ltd. | 2026-02-13 |
| K251581 | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | Shenzhen Hingmed Medical Instrument Co., Ltd. | 2026-02-13 |
| K251307 | Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) | Shenzhen Hingmed Medical Instrument Co., Ltd. | 2026-01-12 |
| K253142 | Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) | Ningbo Ranor Medical Technology Co., Ltd. | 2026-01-09 |