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FDA 510(k)

KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0

K-Number: K051127 · 2005-06-03

ApplicantKika Medical, Inc.
Decision Date2005-06-03
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Kika Medical, Inc.. It received FDA 510(k) clearance on 2005-06-03 under 510(k) number K051127. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0?

KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0 is a medical device that received FDA 510(k) clearance on 2005-06-03. The listed applicant is Kika Medical, Inc.. The 510(k) number is K051127.

When did KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0 receive FDA 510(k) clearance?

KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0 received FDA 510(k) clearance on 2005-06-03, under 510(k) number K051127.

Who is the listed applicant for KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0?

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

What is the FDA product code for KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0?

The FDA product code for KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0 is LLZ.

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Related Devices (Code: LLZ)

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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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