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FDA 510(k)

Automatic Blood Pressure Monitor Model LD-518 & LD-537

K-Number: K170466 · 2017-10-27

ApplicantHonsun (Nantong) Co., Ltd.
Decision Date2017-10-27
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Automatic Blood Pressure Monitor Model LD-518 & LD-537 is the device name listed in this FDA 510(k) record. The listed applicant is Honsun (Nantong) Co., Ltd.. It received FDA 510(k) clearance on 2017-10-27 under 510(k) number K170466. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Automatic Blood Pressure Monitor Model LD-518 & LD-537?

Automatic Blood Pressure Monitor Model LD-518 & LD-537 is a medical device that received FDA 510(k) clearance on 2017-10-27. The listed applicant is Honsun (Nantong) Co., Ltd.. The 510(k) number is K170466.

When did Automatic Blood Pressure Monitor Model LD-518 & LD-537 receive FDA 510(k) clearance?

Automatic Blood Pressure Monitor Model LD-518 & LD-537 received FDA 510(k) clearance on 2017-10-27, under 510(k) number K170466.

Who is the listed applicant for Automatic Blood Pressure Monitor Model LD-518 & LD-537?

The FDA 510(k) record lists Honsun (Nantong) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Automatic Blood Pressure Monitor Model LD-518 & LD-537?

The FDA product code for Automatic Blood Pressure Monitor Model LD-518 & LD-537 is DXN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06508619Blood Pressure Treatment by the Corsano CardioWatch 287-2 Evaluation StudyCOMPLETEDNCT06969560WeRoaM: Wearable Remote Monitoring in Heart FailureRECRUITINGNCT07713576Clinical Trial of Wrist Ambulatory Blood Pressure Monitor in Conformance With the ISO 81060-2:2018+AMD1:2020+AMD2:2024.COMPLETED

Other records listing Honsun (Nantong) Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252399Portable Oxygen ConcentratorK260260Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)K251795Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)K211629Infrared forehead thermometer LD-FT-100BK192500Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometerK170866Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579

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Related Devices (Code: DXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261061BP Go (BPP-855)Wellvii, Inc.K253425Arm-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.K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd.K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife CorporationK253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.K260693VicorderCS (VCS-SYS-1100)80 Beats Medical GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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