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FDA 510(k)

ULTIMATE 3000

K-Number: K910839 · 1991-07-26

ApplicantFonar Corp.
Decision Date1991-07-26
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTIMATE 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Fonar Corp.. It received FDA 510(k) clearance on 1991-07-26 under 510(k) number K910839. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTIMATE 3000?

ULTIMATE 3000 is a medical device that received FDA 510(k) clearance on 1991-07-26. The listed applicant is Fonar Corp.. The 510(k) number is K910839.

When did ULTIMATE 3000 receive FDA 510(k) clearance?

ULTIMATE 3000 received FDA 510(k) clearance on 1991-07-26, under 510(k) number K910839.

Who is the listed applicant for ULTIMATE 3000?

The FDA 510(k) record lists Fonar Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTIMATE 3000?

The FDA product code for ULTIMATE 3000 is LNH.

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Other records listing Fonar Corp. as applicant

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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Related Devices (Code: LNH)

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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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