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FDA 510(k)

GUAVA EZCD4 SYSTEM

K-Number: K053497 · 2006-04-14

ApplicantGuava Technologies, Inc.
Decision Date2006-04-14
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GUAVA EZCD4 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Guava Technologies, Inc.. It received FDA 510(k) clearance on 2006-04-14 under 510(k) number K053497. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUAVA EZCD4 SYSTEM?

GUAVA EZCD4 SYSTEM is a medical device that received FDA 510(k) clearance on 2006-04-14. The listed applicant is Guava Technologies, Inc.. The 510(k) number is K053497.

When did GUAVA EZCD4 SYSTEM receive FDA 510(k) clearance?

GUAVA EZCD4 SYSTEM received FDA 510(k) clearance on 2006-04-14, under 510(k) number K053497.

Who is the listed applicant for GUAVA EZCD4 SYSTEM?

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

What is the FDA product code for GUAVA EZCD4 SYSTEM?

The FDA product code for GUAVA EZCD4 SYSTEM is GKZ.

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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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