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FDA 510(k)

DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100

K-Number: K080636 · 2009-02-13

ApplicantHubdic Co., Ltd.
Decision Date2009-02-13
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100 is the device name listed in this FDA 510(k) record. The listed applicant is Hubdic Co., Ltd.. It received FDA 510(k) clearance on 2009-02-13 under 510(k) number K080636. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100?

DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100 is a medical device that received FDA 510(k) clearance on 2009-02-13. The listed applicant is Hubdic Co., Ltd.. The 510(k) number is K080636.

When did DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100 receive FDA 510(k) clearance?

DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100 received FDA 510(k) clearance on 2009-02-13, under 510(k) number K080636.

Who is the listed applicant for DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100?

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

What is the FDA product code for DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100?

The FDA product code for DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100 is CGA.

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Other records listing Hubdic Co., Ltd. as applicant

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Related Devices (Code: CGA)

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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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