510(k) K250116

Device: Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B)
Applicant: Shenzhen AOJ Medical Technology Co., Ltd.
510(k) number: K250116
Product code: DXN
Decision: Substantially Equivalent (SESE)
Decision date: 2025-04-24
Date received: 2025-01-16
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

Related Records

Applicant Contact

Contact: Jack Wang
Address: Rm.301&4f,Block A, Bldg. A,Ingfa Intelligent Manufacturing P Xiaweiyuan, Gushu Community, Xixiang St., Bao'An District Shenzhen CN 518126 518126

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

510(k) summary PDF

Other 510(k) Records For Product Code DXN

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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