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FDA 510(k)

DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES

K-Number: K120675 · 2013-02-14

ApplicantGrandway Technology (Shenzhen) Limited
Decision Date2013-02-14
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Grandway Technology (Shenzhen) Limited. It received FDA 510(k) clearance on 2013-02-14 under 510(k) number K120675. 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 DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES?

DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES is a medical device that received FDA 510(k) clearance on 2013-02-14. The listed applicant is Grandway Technology (Shenzhen) Limited. The 510(k) number is K120675.

When did DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES receive FDA 510(k) clearance?

DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES received FDA 510(k) clearance on 2013-02-14, under 510(k) number K120675.

Who is the listed applicant for DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES?

The FDA 510(k) record lists Grandway Technology (Shenzhen) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES?

The FDA product code for DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES is DXN.

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Other records listing Grandway Technology (Shenzhen) Limited as applicant

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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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