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FDA 510(k)

ORG@NIZER, MODEL VERSION 3.0

K-Number: K030363 · 2003-03-27

ApplicantEbit Sanita, S.P.A.
Decision Date2003-03-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ORG@NIZER, MODEL VERSION 3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Ebit Sanita, S.P.A.. It received FDA 510(k) clearance on 2003-03-27 under 510(k) number K030363. 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 ORG@NIZER, MODEL VERSION 3.0?

ORG@NIZER, MODEL VERSION 3.0 is a medical device that received FDA 510(k) clearance on 2003-03-27. The listed applicant is Ebit Sanita, S.P.A.. The 510(k) number is K030363.

When did ORG@NIZER, MODEL VERSION 3.0 receive FDA 510(k) clearance?

ORG@NIZER, MODEL VERSION 3.0 received FDA 510(k) clearance on 2003-03-27, under 510(k) number K030363.

Who is the listed applicant for ORG@NIZER, MODEL VERSION 3.0?

The FDA 510(k) record lists Ebit Sanita, S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORG@NIZER, MODEL VERSION 3.0?

The FDA product code for ORG@NIZER, MODEL VERSION 3.0 is LLZ.

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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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