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FDA 510(k)

UROVIEW 2000, MODIFICATION

K-Number: K914446 · 1992-01-10

ApplicantOec-Diasonics, Inc.
Decision Date1992-01-10
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UROVIEW 2000, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Oec-Diasonics, Inc.. It received FDA 510(k) clearance on 1992-01-10 under 510(k) number K914446. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROVIEW 2000, MODIFICATION?

UROVIEW 2000, MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-01-10. The listed applicant is Oec-Diasonics, Inc.. The 510(k) number is K914446.

When did UROVIEW 2000, MODIFICATION receive FDA 510(k) clearance?

UROVIEW 2000, MODIFICATION received FDA 510(k) clearance on 1992-01-10, under 510(k) number K914446.

Who is the listed applicant for UROVIEW 2000, MODIFICATION?

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

What is the FDA product code for UROVIEW 2000, MODIFICATION?

The FDA product code for UROVIEW 2000, MODIFICATION is JAA.

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Other records listing Oec-Diasonics, 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.

K9260569600 FLUOROSCOPIC IMAGING SYSTEMK924879EP 3000K896583F.A.S.T. TABLEK893475UROVIEW IIK872022UROVIEWK864837MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM

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Related Devices (Code: JAA)

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.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

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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