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FDA 510(k)

QardioArm 2

K-Number: K220106 · 2022-06-15

ApplicantQardio, Inc.
Decision Date2022-06-15
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QardioArm 2 is the device name listed in this FDA 510(k) record. The listed applicant is Qardio, Inc.. It received FDA 510(k) clearance on 2022-06-15 under 510(k) number K220106. 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 QardioArm 2?

QardioArm 2 is a medical device that received FDA 510(k) clearance on 2022-06-15. The listed applicant is Qardio, Inc.. The 510(k) number is K220106.

When did QardioArm 2 receive FDA 510(k) clearance?

QardioArm 2 received FDA 510(k) clearance on 2022-06-15, under 510(k) number K220106.

Who is the listed applicant for QardioArm 2?

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

What is the FDA product code for QardioArm 2?

The FDA product code for QardioArm 2 is DXN.

Other records listing Qardio, 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.

K201644QardioCore

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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