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FDA 510(k)

HEM-9000AI

K-Number: K081654 · 2008-10-10

ApplicantOmron Healthcare, Inc.
Decision Date2008-10-10
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEM-9000AI is the device name listed in this FDA 510(k) record. The listed applicant is Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2008-10-10 under 510(k) number K081654. 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 HEM-9000AI?

HEM-9000AI is a medical device that received FDA 510(k) clearance on 2008-10-10. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K081654.

When did HEM-9000AI receive FDA 510(k) clearance?

HEM-9000AI received FDA 510(k) clearance on 2008-10-10, under 510(k) number K081654.

Who is the listed applicant for HEM-9000AI?

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

What is the FDA product code for HEM-9000AI?

The FDA product code for HEM-9000AI is DXN.

Other records listing Omron Healthcare, 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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