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FDA 510(k)

FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR

K-Number: K070209 · 2007-08-08

ApplicantFego Precision Industrial Co;, Ltd.
Decision Date2007-08-08
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Fego Precision Industrial Co;, Ltd.. It received FDA 510(k) clearance on 2007-08-08 under 510(k) number K070209. 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 FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR?

FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 2007-08-08. The listed applicant is Fego Precision Industrial Co;, Ltd.. The 510(k) number is K070209.

When did FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR receive FDA 510(k) clearance?

FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR received FDA 510(k) clearance on 2007-08-08, under 510(k) number K070209.

Who is the listed applicant for FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR?

The FDA 510(k) record lists Fego Precision Industrial Co;, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR?

The FDA product code for FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR is DXN.

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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.

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