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FDA 510(k)

Microlife Upper Arm Automatic Digital Blood Pressure Monitor

K-Number: K153077 · 2016-02-12

ApplicantMicrolife Intellectual Property GmbH
Decision Date2016-02-12
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Microlife Upper Arm Automatic Digital Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Microlife Intellectual Property GmbH. It received FDA 510(k) clearance on 2016-02-12 under 510(k) number K153077. 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 Microlife Upper Arm Automatic Digital Blood Pressure Monitor?

Microlife Upper Arm Automatic Digital Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2016-02-12. The listed applicant is Microlife Intellectual Property GmbH. The 510(k) number is K153077.

When did Microlife Upper Arm Automatic Digital Blood Pressure Monitor receive FDA 510(k) clearance?

Microlife Upper Arm Automatic Digital Blood Pressure Monitor received FDA 510(k) clearance on 2016-02-12, under 510(k) number K153077.

Who is the listed applicant for Microlife Upper Arm Automatic Digital Blood Pressure Monitor?

The FDA 510(k) record lists Microlife Intellectual Property GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microlife Upper Arm Automatic Digital Blood Pressure Monitor?

The FDA product code for Microlife Upper Arm Automatic Digital Blood Pressure Monitor is DXN.

Related Clinical Trials

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Other records listing Microlife Intellectual Property GmbH 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.

K230075Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5KK222979Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5WK222153Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)K211776Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)K211288Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4BK202729Microlife Upper Arm Automatic Digital Blood Pressure Monitor

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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.

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