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FDA 510(k)

BARD(R) UROTACK(R) 210 MONITORING SYSTEM

K-Number: K912374 · 1992-03-31

ApplicantC.R. Bard, Inc.
Decision Date1992-03-31
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BARD(R) UROTACK(R) 210 MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 1992-03-31 under 510(k) number K912374. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARD(R) UROTACK(R) 210 MONITORING SYSTEM?

BARD(R) UROTACK(R) 210 MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1992-03-31. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K912374.

When did BARD(R) UROTACK(R) 210 MONITORING SYSTEM receive FDA 510(k) clearance?

BARD(R) UROTACK(R) 210 MONITORING SYSTEM received FDA 510(k) clearance on 1992-03-31, under 510(k) number K912374.

Who is the listed applicant for BARD(R) UROTACK(R) 210 MONITORING SYSTEM?

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

What is the FDA product code for BARD(R) UROTACK(R) 210 MONITORING SYSTEM?

The FDA product code for BARD(R) UROTACK(R) 210 MONITORING SYSTEM is KOC.

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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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