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FDA 510(k)

KADANCE 2000

K-Number: K012492 · 2001-11-02

ApplicantKada Research, Inc.
Decision Date2001-11-02
Product CodeLBB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KADANCE 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Kada Research, Inc.. It received FDA 510(k) clearance on 2001-11-02 under 510(k) number K012492. The device is classified under product code LBB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KADANCE 2000?

KADANCE 2000 is a medical device that received FDA 510(k) clearance on 2001-11-02. The listed applicant is Kada Research, Inc.. The 510(k) number is K012492.

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

KADANCE 2000 received FDA 510(k) clearance on 2001-11-02, under 510(k) number K012492.

Who is the listed applicant for KADANCE 2000?

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

What is the FDA product code for KADANCE 2000?

The FDA product code for KADANCE 2000 is LBB.

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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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