FDA 510(k)

ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000

K-Number: K040926 · 2004-06-10

Decision Date2004-06-10

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000 is the device name listed in this FDA 510(k) record. The listed applicant is Hudson Diagnostic Imaging, LLC. It received FDA 510(k) clearance on 2004-06-10 under 510(k) number K040926. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000?

ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000 is a medical device that received FDA 510(k) clearance on 2004-06-10. The listed applicant is Hudson Diagnostic Imaging, LLC. The 510(k) number is K040926.

When did ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000 receive FDA 510(k) clearance?

ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000 received FDA 510(k) clearance on 2004-06-10, under 510(k) number K040926.

Who is the listed applicant for ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000?

The FDA 510(k) record lists Hudson Diagnostic Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000?

The FDA product code for ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000 is IYN.

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Other records listing Hudson Diagnostic Imaging, LLC as applicant

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Related Devices (Code: IYN)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.