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FDA 510(k)

ISOTRON III, ISOTRON IV

K-Number: K955387 · 1996-03-22

ApplicantExcel Tech. , Ltd.
Decision Date1996-03-22
Product CodeLIH
Advisory CommitteeNE
DecisionSubstantially Equivalent for Some Indications

Device Summary

ISOTRON III, ISOTRON IV 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 1996-03-22 under 510(k) number K955387. 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 IV?

ISOTRON III, ISOTRON IV is a medical device that received FDA 510(k) clearance on 1996-03-22. The listed applicant is Excel Tech. , Ltd.. The 510(k) number is K955387.

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

ISOTRON III, ISOTRON IV received FDA 510(k) clearance on 1996-03-22, under 510(k) number K955387.

Who is the listed applicant for ISOTRON III, ISOTRON IV?

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, ISOTRON IV?

The FDA product code for ISOTRON III, ISOTRON IV 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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