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FDA 510(k)

AVITA WRIST TYPE BLOOD PRESSURE MONITOR

K-Number: K102624 · 2010-12-16

ApplicantAvita Corporation
Decision Date2010-12-16
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AVITA WRIST TYPE BLOOD PRESSURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Avita Corporation. It received FDA 510(k) clearance on 2010-12-16 under 510(k) number K102624. 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 AVITA WRIST TYPE BLOOD PRESSURE MONITOR?

AVITA WRIST TYPE BLOOD PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 2010-12-16. The listed applicant is Avita Corporation. The 510(k) number is K102624.

When did AVITA WRIST TYPE BLOOD PRESSURE MONITOR receive FDA 510(k) clearance?

AVITA WRIST TYPE BLOOD PRESSURE MONITOR received FDA 510(k) clearance on 2010-12-16, under 510(k) number K102624.

Who is the listed applicant for AVITA WRIST TYPE BLOOD PRESSURE MONITOR?

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 AVITA WRIST TYPE BLOOD PRESSURE MONITOR?

The FDA product code for AVITA WRIST TYPE BLOOD PRESSURE MONITOR is DXN.

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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.

K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc.K254000Happy Health Blood Pressure MonitorHappy Health, Inc.K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd.K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)JOYTECH Healthcare Co., Ltd.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.K261061BP Go (BPP-855)Wellvii, Inc.

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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