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FDA 510(k)

AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS

K-Number: K912588 · 1991-12-19

ApplicantSein Electronics Co., Ltd.
Decision Date1991-12-19
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS is the device name listed in this FDA 510(k) record. The listed applicant is Sein Electronics Co., Ltd.. It received FDA 510(k) clearance on 1991-12-19 under 510(k) number K912588. 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 AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS?

AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS is a medical device that received FDA 510(k) clearance on 1991-12-19. The listed applicant is Sein Electronics Co., Ltd.. The 510(k) number is K912588.

When did AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS receive FDA 510(k) clearance?

AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS received FDA 510(k) clearance on 1991-12-19, under 510(k) number K912588.

Who is the listed applicant for AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS?

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

What is the FDA product code for AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS?

The FDA product code for AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS is DXN.

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Other records listing Sein Electronics 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.

K052108SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100K042138FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311K042014DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400K032927FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITORK012054FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312K003711AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P

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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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