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FDA 510(k)

Arm Type Blood Pressure Monitor (BPM82)

K-Number: K242193 · 2024-10-22

ApplicantAvita Corporation
Decision Date2024-10-22
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Arm Type Blood Pressure Monitor (BPM82) is the device name listed in this FDA 510(k) record. The listed applicant is Avita Corporation. It received FDA 510(k) clearance on 2024-10-22 under 510(k) number K242193. 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 Type Blood Pressure Monitor (BPM82)?

Arm Type Blood Pressure Monitor (BPM82) is a medical device that received FDA 510(k) clearance on 2024-10-22. The listed applicant is Avita Corporation. The 510(k) number is K242193.

When did Arm Type Blood Pressure Monitor (BPM82) receive FDA 510(k) clearance?

Arm Type Blood Pressure Monitor (BPM82) received FDA 510(k) clearance on 2024-10-22, under 510(k) number K242193.

Who is the listed applicant for Arm Type Blood Pressure Monitor (BPM82)?

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

What is the FDA product code for Arm Type Blood Pressure Monitor (BPM82)?

The FDA product code for Arm Type Blood Pressure Monitor (BPM82) is DXN.

Other records listing Avita Corporation 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.

K250129AViTA Breast PumpK252448AViTA Pulse Oximeter (SP61)K250765AViTA Arm Type Blood Pressure Monitor CuffK242455AViTA Pulse Oximeter (SP62B)K241852Nasal Aspirator (NS 13)K223399AViTA Pulse Oximeter

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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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