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FDA 510(k)

ISOTRON III

K-Number: K941815 · 1995-05-03

ApplicantExcel Tech. , Ltd.
Decision Date1995-05-03
Product CodeLIH
Advisory CommitteeNE
DecisionSubstantially Equivalent for Some Indications

Device Summary

ISOTRON III is the device name listed in this FDA 510(k) record. The listed applicant is Excel Tech. , Ltd.. It received FDA 510(k) clearance on 1995-05-03 under 510(k) number K941815. The device is classified under product code LIH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ISOTRON III?

ISOTRON III is a medical device that received FDA 510(k) clearance on 1995-05-03. The listed applicant is Excel Tech. , Ltd.. The 510(k) number is K941815.

When did ISOTRON III receive FDA 510(k) clearance?

ISOTRON III received FDA 510(k) clearance on 1995-05-03, under 510(k) number K941815.

Who is the listed applicant for ISOTRON III?

The FDA 510(k) record lists Excel Tech. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISOTRON III?

The FDA product code for ISOTRON III is LIH.

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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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