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FDA 510(k)

CADWELL DISPOSABLE PROBE HANDLE

K-Number: K123589 · 2013-03-19

ApplicantCadwell
Decision Date2013-03-19
Product CodePDQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CADWELL DISPOSABLE PROBE HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is Cadwell. It received FDA 510(k) clearance on 2013-03-19 under 510(k) number K123589. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CADWELL DISPOSABLE PROBE HANDLE?

CADWELL DISPOSABLE PROBE HANDLE is a medical device that received FDA 510(k) clearance on 2013-03-19. The listed applicant is Cadwell. The 510(k) number is K123589.

When did CADWELL DISPOSABLE PROBE HANDLE receive FDA 510(k) clearance?

CADWELL DISPOSABLE PROBE HANDLE received FDA 510(k) clearance on 2013-03-19, under 510(k) number K123589.

Who is the listed applicant for CADWELL DISPOSABLE PROBE HANDLE?

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

What is the FDA product code for CADWELL DISPOSABLE PROBE HANDLE?

The FDA product code for CADWELL DISPOSABLE PROBE HANDLE is PDQ.

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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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