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FDA 510(k)

MULTIFUNCTION KEITO K5

K-Number: K984083 · 2000-01-18

ApplicantBumedco Intl., Inc.
Decision Date2000-01-18
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MULTIFUNCTION KEITO K5 is the device name listed in this FDA 510(k) record. The listed applicant is Bumedco Intl., Inc.. It received FDA 510(k) clearance on 2000-01-18 under 510(k) number K984083. 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 MULTIFUNCTION KEITO K5?

MULTIFUNCTION KEITO K5 is a medical device that received FDA 510(k) clearance on 2000-01-18. The listed applicant is Bumedco Intl., Inc.. The 510(k) number is K984083.

When did MULTIFUNCTION KEITO K5 receive FDA 510(k) clearance?

MULTIFUNCTION KEITO K5 received FDA 510(k) clearance on 2000-01-18, under 510(k) number K984083.

Who is the listed applicant for MULTIFUNCTION KEITO K5?

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

What is the FDA product code for MULTIFUNCTION KEITO K5?

The FDA product code for MULTIFUNCTION KEITO K5 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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