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FDA 510(k)

I-DIXEL

K-Number: K073704 · 2008-02-21

ApplicantJ. Morita USA, Inc.
Decision Date2008-02-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

I-DIXEL is the device name listed in this FDA 510(k) record. The listed applicant is J. Morita USA, Inc.. It received FDA 510(k) clearance on 2008-02-21 under 510(k) number K073704. 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 I-DIXEL?

I-DIXEL is a medical device that received FDA 510(k) clearance on 2008-02-21. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K073704.

When did I-DIXEL receive FDA 510(k) clearance?

I-DIXEL received FDA 510(k) clearance on 2008-02-21, under 510(k) number K073704.

Who is the listed applicant for I-DIXEL?

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

What is the FDA product code for I-DIXEL?

The FDA product code for I-DIXEL is 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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