FDA 510(k)

Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579

K-Number: K170866 · 2018-02-21

Decision Date2018-02-21

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 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 2018-02-21 under 510(k) number K170866. 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 Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579?

Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 is a medical device that received FDA 510(k) clearance on 2018-02-21. The listed applicant is Honsun (Nantong) Co., Ltd.. The 510(k) number is K170866.

When did Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 receive FDA 510(k) clearance?

Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 received FDA 510(k) clearance on 2018-02-21, under 510(k) number K170866.

Who is the listed applicant for Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579?

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 Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579?

The FDA product code for Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 is DXN.

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

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Related Devices (Code: DXN)

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 Corporation K253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.K260693VicorderCS (VCS-SYS-1100)80 Beats Medical GmbH

Official Source

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