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FDA 510(k)

ULTRA IV

K-Number: K960489 · 1996-03-27

ApplicantExcel Tech. , Ltd.
Decision Date1996-03-27
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

ULTRA 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 1996-03-27 under 510(k) number K960489. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ULTRA IV?

ULTRA IV is a medical device that received FDA 510(k) clearance on 1996-03-27. The listed applicant is Excel Tech. , Ltd.. The 510(k) number is K960489.

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

ULTRA IV received FDA 510(k) clearance on 1996-03-27, under 510(k) number K960489.

Who is the listed applicant for ULTRA 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 ULTRA IV?

The FDA product code for ULTRA IV is IPF.

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Other records listing Excel Tech. , Ltd. as applicant

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Related Devices (Code: IPF)

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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