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FDA 510(k)

Reprocessed Kendall SCD Express Foot Cuff

K-Number: K163055 · 2016-12-23

ApplicantCovidien
Decision Date2016-12-23
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Kendall SCD Express Foot Cuff is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2016-12-23 under approval number K163055. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed Kendall SCD Express Foot Cuff?

Reprocessed Kendall SCD Express Foot Cuff is a medical device that received FDA 510(k) clearance on 2016-12-23. It is manufactured by Covidien. The 510(k) number is K163055.

When was Reprocessed Kendall SCD Express Foot Cuff approved by the FDA?

Reprocessed Kendall SCD Express Foot Cuff received FDA 510(k) clearance on 2016-12-23, under approval number K163055.

What company makes Reprocessed Kendall SCD Express Foot Cuff?

Reprocessed Kendall SCD Express Foot Cuff is manufactured by Covidien.

What is the FDA product code for Reprocessed Kendall SCD Express Foot Cuff?

The FDA product code for Reprocessed Kendall SCD Express Foot Cuff is JOW.

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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.