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510(k) K160552

Device
EV1000 Clinical Platform With ClearSight Finger Cuff Or ClearSight System, EV1000 Clinical Platform
Applicant
EDWARDS LIFESCIENCES, LLC
510(k) number
K160552
Product code
DXN  
Decision
Substantially Equivalent (SESE)
Decision date
2016-06-01
Date received
2016-02-29
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
Tara Viviani
Address
One Edwards Way Irvine CA US 92614 92614

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DXN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253570Blood Pressure Monitor (W06LT)Shenzhen Jamr Technology Co., Ltd.2026-05-20
K254048Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)Shenzhen Urion Technology Co., Ltd.2026-05-14
K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC2026-05-06
K260260Automatic 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
K252501Arm-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
K253982Korotkoff sound blood pressure monitorBeijing Hanvon Health Technology Co., Ltd.2026-04-21
K260276Arm 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 ProShenzhen AOJ Medical Technology Co., Ltd.2026-04-01
K254225Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)Shenzhen HanHan Technology Co., Ltd.2026-04-01
K260273Automatic 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
K252779YUWELL® Electronic Blood Pressure Monitor (YE630CR)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2026-03-05
K253228YUWELL® Electronic Blood Pressure Monitor (YE650AR)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2026-02-23
K253133Wrist Blood Pressure Monitor (BPM-W1VL)Shenzhen Imdk Medical Technology Co., Ltd.2026-02-13
K252685Arm-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
K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd.2026-02-13
K251307Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)Shenzhen Hingmed Medical Instrument Co., Ltd.2026-01-12

Legacy Summary#

summary

FDA Review#

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