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FDA 510(k)

F-400 SYSTEM

K-Number: K051585 · 2005-09-06

ApplicantMauna Kea Technologies
Decision Date2005-09-06
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

F-400 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mauna Kea Technologies. It received FDA 510(k) clearance on 2005-09-06 under 510(k) number K051585. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F-400 SYSTEM?

F-400 SYSTEM is a medical device that received FDA 510(k) clearance on 2005-09-06. The listed applicant is Mauna Kea Technologies. The 510(k) number is K051585.

When did F-400 SYSTEM receive FDA 510(k) clearance?

F-400 SYSTEM received FDA 510(k) clearance on 2005-09-06, under 510(k) number K051585.

Who is the listed applicant for F-400 SYSTEM?

The FDA 510(k) record lists Mauna Kea Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for F-400 SYSTEM?

The FDA product code for F-400 SYSTEM is GCJ.

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Related Devices (Code: GCJ)

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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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