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FDA 510(k)

GMC Upper Arm Automatic Blood Pressure Monitor

K-Number: K181931 · 2019-04-04

ApplicantGmc, Inc.
Decision Date2019-04-04
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GMC Upper Arm Automatic Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Gmc, Inc.. It received FDA 510(k) clearance on 2019-04-04 under 510(k) number K181931. 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 GMC Upper Arm Automatic Blood Pressure Monitor?

GMC Upper Arm Automatic Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2019-04-04. The listed applicant is Gmc, Inc.. The 510(k) number is K181931.

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

GMC Upper Arm Automatic Blood Pressure Monitor received FDA 510(k) clearance on 2019-04-04, under 510(k) number K181931.

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

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

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

The FDA product code for GMC Upper Arm Automatic 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.

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Other records listing Gmc, Inc. 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.

K181930GMC Wrist Automatic 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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