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FDA 510(k)

HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F

K-Number: K081073 · 2008-12-05

ApplicantPausch, LLC
Decision Date2008-12-05
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F is the device name listed in this FDA 510(k) record. The listed applicant is Pausch, LLC. It received FDA 510(k) clearance on 2008-12-05 under 510(k) number K081073. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F?

HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F is a medical device that received FDA 510(k) clearance on 2008-12-05. The listed applicant is Pausch, LLC. The 510(k) number is K081073.

When did HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F receive FDA 510(k) clearance?

HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F received FDA 510(k) clearance on 2008-12-05, under 510(k) number K081073.

Who is the listed applicant for HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F?

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

What is the FDA product code for HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F?

The FDA product code for HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F is OWB.

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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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