Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Wrist Electronic Sphygmomanometer

K-Number: K193386 · 2021-01-27

ApplicantShenzhen Changkun Technology Co., Ltd.
Decision Date2021-01-27
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Wrist Electronic Sphygmomanometer is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Changkun Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-01-27 under 510(k) number K193386. 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 Wrist Electronic Sphygmomanometer?

Wrist Electronic Sphygmomanometer is a medical device that received FDA 510(k) clearance on 2021-01-27. The listed applicant is Shenzhen Changkun Technology Co., Ltd.. The 510(k) number is K193386.

When did Wrist Electronic Sphygmomanometer receive FDA 510(k) clearance?

Wrist Electronic Sphygmomanometer received FDA 510(k) clearance on 2021-01-27, under 510(k) number K193386.

Who is the listed applicant for Wrist Electronic Sphygmomanometer?

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

What is the FDA product code for Wrist Electronic Sphygmomanometer?

The FDA product code for Wrist Electronic Sphygmomanometer is DXN.

Other records listing Shenzhen Changkun 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.

K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)K231595Electric Breast PumpK221798Finger Pulse Oximeter, Model: X1906PK193387Arm Electronic SphygmomanometerK193253Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503

View all 7 devices →

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.

↑