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FDA 510(k)

1500 PRO

K-Number: K080289 · 2008-02-26

ApplicantOmron Healthcare, Inc.
Decision Date2008-02-26
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

1500 PRO 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 2008-02-26 under 510(k) number K080289. 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 1500 PRO?

1500 PRO is a medical device that received FDA 510(k) clearance on 2008-02-26. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K080289.

When did 1500 PRO receive FDA 510(k) clearance?

1500 PRO received FDA 510(k) clearance on 2008-02-26, under 510(k) number K080289.

Who is the listed applicant for 1500 PRO?

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 1500 PRO?

The FDA product code for 1500 PRO 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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