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FDA 510(k)

Occlusion Detection Dressing Kit

K-Number: K171499 · 2017-09-22

ApplicantCardinalhealth
Decision Date2017-09-22
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Occlusion Detection Dressing Kit is the device name listed in this FDA 510(k) record. The listed applicant is Cardinalhealth. It received FDA 510(k) clearance on 2017-09-22 under 510(k) number K171499. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Occlusion Detection Dressing Kit?

Occlusion Detection Dressing Kit is a medical device that received FDA 510(k) clearance on 2017-09-22. The listed applicant is Cardinalhealth. The 510(k) number is K171499.

When did Occlusion Detection Dressing Kit receive FDA 510(k) clearance?

Occlusion Detection Dressing Kit received FDA 510(k) clearance on 2017-09-22, under 510(k) number K171499.

Who is the listed applicant for Occlusion Detection Dressing Kit?

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

What is the FDA product code for Occlusion Detection Dressing Kit?

The FDA product code for Occlusion Detection Dressing Kit is OMP.

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Related Devices (Code: OMP)

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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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