FDA 510(k)

FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312

K-Number: K012054 · 2001-08-08

Decision Date2001-08-08

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312 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 2001-08-08 under 510(k) number K012054. 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 FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312?

FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312 is a medical device that received FDA 510(k) clearance on 2001-08-08. The listed applicant is Sein Electronics Co., Ltd.. The 510(k) number is K012054.

When did FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312 receive FDA 510(k) clearance?

FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312 received FDA 510(k) clearance on 2001-08-08, under 510(k) number K012054.

Who is the listed applicant for FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312?

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 FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312?

The FDA product code for FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312 is DXN.

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Other records listing Sein Electronics Co., Ltd. as applicant

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Related Devices (Code: DXN)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.