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FDA 510(k)

IMAGE STORAGE SYSTEM, MODEL KSS-400

K-Number: K081797 · 2009-01-22

ApplicantKonan Medical, Inc.
Decision Date2009-01-22
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGE STORAGE SYSTEM, MODEL KSS-400 is the device name listed in this FDA 510(k) record. The listed applicant is Konan Medical, Inc.. It received FDA 510(k) clearance on 2009-01-22 under 510(k) number K081797. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGE STORAGE SYSTEM, MODEL KSS-400?

IMAGE STORAGE SYSTEM, MODEL KSS-400 is a medical device that received FDA 510(k) clearance on 2009-01-22. The listed applicant is Konan Medical, Inc.. The 510(k) number is K081797.

When did IMAGE STORAGE SYSTEM, MODEL KSS-400 receive FDA 510(k) clearance?

IMAGE STORAGE SYSTEM, MODEL KSS-400 received FDA 510(k) clearance on 2009-01-22, under 510(k) number K081797.

Who is the listed applicant for IMAGE STORAGE SYSTEM, MODEL KSS-400?

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

What is the FDA product code for IMAGE STORAGE SYSTEM, MODEL KSS-400?

The FDA product code for IMAGE STORAGE SYSTEM, MODEL KSS-400 is NFJ.

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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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