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FDA 510(k)

DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400

K-Number: K042014 · 2004-08-06

ApplicantSein Electronics Co., Ltd.
Decision Date2004-08-06
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400 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 2004-08-06 under 510(k) number K042014. 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 BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400?

DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400 is a medical device that received FDA 510(k) clearance on 2004-08-06. The listed applicant is Sein Electronics Co., Ltd.. The 510(k) number is K042014.

When did DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400 receive FDA 510(k) clearance?

DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400 received FDA 510(k) clearance on 2004-08-06, under 510(k) number K042014.

Who is the listed applicant for DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400?

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 DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400?

The FDA product code for DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400 is DXN.

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Other records listing Sein Electronics Co., Ltd. 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.

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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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