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FDA 510(k)

OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-401C

K-Number: K871207 · 1987-05-28

ApplicantOmron Electronics, Inc.
Decision Date1987-05-28
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-401C is the device name listed in this FDA 510(k) record. The listed applicant is Omron Electronics, Inc.. It received FDA 510(k) clearance on 1987-05-28 under 510(k) number K871207. 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 OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-401C?

OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-401C is a medical device that received FDA 510(k) clearance on 1987-05-28. The listed applicant is Omron Electronics, Inc.. The 510(k) number is K871207.

When did OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-401C receive FDA 510(k) clearance?

OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-401C received FDA 510(k) clearance on 1987-05-28, under 510(k) number K871207.

Who is the listed applicant for OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-401C?

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

What is the FDA product code for OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-401C?

The FDA product code for OMRON DIGITAL BLOOD PRESSURE MONITOR HEM-401C is DXN.

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Other records listing Omron Electronics, Inc. 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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