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FDA 510(k)

MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION

K-Number: K013620 · 2002-01-22

ApplicantMedstone Intl., Inc.
Decision Date2002-01-22
Product CodeIZF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Medstone Intl., Inc.. It received FDA 510(k) clearance on 2002-01-22 under 510(k) number K013620. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION?

MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION is a medical device that received FDA 510(k) clearance on 2002-01-22. The listed applicant is Medstone Intl., Inc.. The 510(k) number is K013620.

When did MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION receive FDA 510(k) clearance?

MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION received FDA 510(k) clearance on 2002-01-22, under 510(k) number K013620.

Who is the listed applicant for MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION?

The FDA 510(k) record lists Medstone Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION?

The FDA product code for MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION is IZF.

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Other records listing Medstone Intl., Inc. 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: IZF)

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

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

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