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FDA 510(k)

Arm Blood Pressure Monitor

K-Number: K192023 · 2019-12-23

ApplicantTruly Instrument Limited
Decision Date2019-12-23
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Arm Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Truly Instrument Limited. It received FDA 510(k) clearance on 2019-12-23 under 510(k) number K192023. 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 Arm Blood Pressure Monitor?

Arm Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2019-12-23. The listed applicant is Truly Instrument Limited. The 510(k) number is K192023.

When did Arm Blood Pressure Monitor receive FDA 510(k) clearance?

Arm Blood Pressure Monitor received FDA 510(k) clearance on 2019-12-23, under 510(k) number K192023.

Who is the listed applicant for Arm Blood Pressure Monitor?

The FDA 510(k) record lists Truly Instrument Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arm Blood Pressure Monitor?

The FDA product code for Arm Blood Pressure Monitor is DXN.

Other records listing Truly Instrument Limited 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.

K220276Infrared Thermometer TET-351K170545Automatic Wrist Bluetooth Blood Pressure MonitorK161846Automatic Arm Bluetooth 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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