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)

InBody Blood pressure monitor, Model BPBIO480KV

K-Number: K221764 · 2022-10-07

ApplicantInbody Co., Ltd.
Decision Date2022-10-07
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

InBody Blood pressure monitor, Model BPBIO480KV is the device name listed in this FDA 510(k) record. The listed applicant is Inbody Co., Ltd.. It received FDA 510(k) clearance on 2022-10-07 under 510(k) number K221764. 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 InBody Blood pressure monitor, Model BPBIO480KV?

InBody Blood pressure monitor, Model BPBIO480KV is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is Inbody Co., Ltd.. The 510(k) number is K221764.

When did InBody Blood pressure monitor, Model BPBIO480KV receive FDA 510(k) clearance?

InBody Blood pressure monitor, Model BPBIO480KV received FDA 510(k) clearance on 2022-10-07, under 510(k) number K221764.

Who is the listed applicant for InBody Blood pressure monitor, Model BPBIO480KV?

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

What is the FDA product code for InBody Blood pressure monitor, Model BPBIO480KV?

The FDA product code for InBody Blood pressure monitor, Model BPBIO480KV 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 FailureRECRUITINGNCT07713576Clinical Trial of Wrist Ambulatory Blood Pressure Monitor in Conformance With the ISO 81060-2:2018+AMD1:2020+AMD2:2024.COMPLETED

Other records listing Inbody 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.

K231174BPBIO750K200560InBodyK200442InBody

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.

↑