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FDA 510(k)

UROMAT 2000

K-Number: K903395 · 1990-08-30

ApplicantPausch Corp.
Decision Date1990-08-30
Product CodeIXR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UROMAT 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Pausch Corp.. It received FDA 510(k) clearance on 1990-08-30 under 510(k) number K903395. The device is classified under product code IXR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROMAT 2000?

UROMAT 2000 is a medical device that received FDA 510(k) clearance on 1990-08-30. The listed applicant is Pausch Corp.. The 510(k) number is K903395.

When did UROMAT 2000 receive FDA 510(k) clearance?

UROMAT 2000 received FDA 510(k) clearance on 1990-08-30, under 510(k) number K903395.

Who is the listed applicant for UROMAT 2000?

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

What is the FDA product code for UROMAT 2000?

The FDA product code for UROMAT 2000 is IXR.

Related Clinical Trials

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.

Other records listing Pausch 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.

View all 8 devices →

Related Devices (Code: IXR)

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.

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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