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FDA 510(k)

WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES

K-Number: K041693 · 2004-12-02

ApplicantHangzhou Hua'An Medical & Health Instruments Co.,
Decision Date2004-12-02
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Hua'An Medical & Health Instruments Co.,. It received FDA 510(k) clearance on 2004-12-02 under 510(k) number K041693. 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 WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES?

WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES is a medical device that received FDA 510(k) clearance on 2004-12-02. The listed applicant is Hangzhou Hua'An Medical & Health Instruments Co.,. The 510(k) number is K041693.

When did WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES receive FDA 510(k) clearance?

WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES received FDA 510(k) clearance on 2004-12-02, under 510(k) number K041693.

Who is the listed applicant for WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES?

The FDA 510(k) record lists Hangzhou Hua'An Medical & Health Instruments Co., as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES?

The FDA product code for WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES is DXN.

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Other records listing Hangzhou Hua'An Medical & Health Instruments Co., 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.

K122912DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)K092447DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIESK092514UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIESK041694DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETERK041692INFRARED EAR THERMOMETER, ET-100 SERIESK030361JASUN, MODELS DT-01F AND DT-11F

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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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