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FDA 510(k)

MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901

K-Number: K071384 · 2007-10-09

ApplicantNihon Seimitsu Sokki Co., Ltd.
Decision Date2007-10-09
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901 is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Seimitsu Sokki Co., Ltd.. It received FDA 510(k) clearance on 2007-10-09 under 510(k) number K071384. 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 MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901?

MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901 is a medical device that received FDA 510(k) clearance on 2007-10-09. The listed applicant is Nihon Seimitsu Sokki Co., Ltd.. The 510(k) number is K071384.

When did MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901 receive FDA 510(k) clearance?

MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901 received FDA 510(k) clearance on 2007-10-09, under 510(k) number K071384.

Who is the listed applicant for MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901?

The FDA 510(k) record lists Nihon Seimitsu Sokki Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901?

The FDA product code for MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901 is DXN.

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Other records listing Nihon Seimitsu Sokki Co., Ltd. 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.

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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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