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FDA 510(k)

Bluetooth blood pressure monitor

K-Number: K161530 · 2017-03-31

ApplicantShenzhen Kingyield Technology Co., Ltd.
Decision Date2017-03-31
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Bluetooth blood pressure monitor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kingyield Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-03-31 under 510(k) number K161530. 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 Bluetooth blood pressure monitor?

Bluetooth blood pressure monitor is a medical device that received FDA 510(k) clearance on 2017-03-31. The listed applicant is Shenzhen Kingyield Technology Co., Ltd.. The 510(k) number is K161530.

When did Bluetooth blood pressure monitor receive FDA 510(k) clearance?

Bluetooth blood pressure monitor received FDA 510(k) clearance on 2017-03-31, under 510(k) number K161530.

Who is the listed applicant for Bluetooth blood pressure monitor?

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

What is the FDA product code for Bluetooth blood pressure monitor?

The FDA product code for Bluetooth blood pressure monitor 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.

NCT06969560WeRoaM: Wearable Remote Monitoring in Heart FailureRECRUITING

Other records listing Shenzhen Kingyield Technology 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.

K182018Bluetooth blood pressure monitor

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

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