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FDA 510(k)

UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-2050

K-Number: K850316 · 1985-04-16

ApplicantNihon Seimitsu Sokki Co., Ltd.
Decision Date1985-04-16
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-2050 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 1985-04-16 under 510(k) number K850316. 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 UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-2050?

UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-2050 is a medical device that received FDA 510(k) clearance on 1985-04-16. The listed applicant is Nihon Seimitsu Sokki Co., Ltd.. The 510(k) number is K850316.

When did UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-2050 receive FDA 510(k) clearance?

UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-2050 received FDA 510(k) clearance on 1985-04-16, under 510(k) number K850316.

Who is the listed applicant for UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-2050?

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 UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-2050?

The FDA product code for UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-2050 is DXN.

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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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