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FDA 510(k)

ULTRA III

K-Number: K921952 · 1993-03-09

ApplicantExcel Tech. , Ltd.
Decision Date1993-03-09
Product CodeIMG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ULTRA 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 1993-03-09 under 510(k) number K921952. The device is classified under product code IMG. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRA III?

ULTRA III is a medical device that received FDA 510(k) clearance on 1993-03-09. The listed applicant is Excel Tech. , Ltd.. The 510(k) number is K921952.

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

ULTRA III received FDA 510(k) clearance on 1993-03-09, under 510(k) number K921952.

Who is the listed applicant for ULTRA 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 ULTRA III?

The FDA product code for ULTRA III is IMG.

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Related Devices (Code: IMG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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