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FDA 510(k)

ISOTRON 220

K-Number: K900823 · 1990-03-26

ApplicantExcel Tech. , Ltd.
Decision Date1990-03-26
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ISOTRON 220 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 1990-03-26 under 510(k) number K900823. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOTRON 220?

ISOTRON 220 is a medical device that received FDA 510(k) clearance on 1990-03-26. The listed applicant is Excel Tech. , Ltd.. The 510(k) number is K900823.

When did ISOTRON 220 receive FDA 510(k) clearance?

ISOTRON 220 received FDA 510(k) clearance on 1990-03-26, under 510(k) number K900823.

Who is the listed applicant for ISOTRON 220?

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 220?

The FDA product code for ISOTRON 220 is IPF.

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Related Devices (Code: IPF)

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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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