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FDA 510(k)

Foley Catheter with Temperature Sensor

K-Number: K200757 · 2020-10-15

ApplicantDeroyal Industries, Inc.
Decision Date2020-10-15
Product CodeEYC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Foley Catheter with Temperature Sensor is a medical device manufactured by Deroyal Industries, Inc.. It received FDA 510(k) clearance on 2020-10-15 under approval number K200757. The device is classified under product code EYC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Foley Catheter with Temperature Sensor?

Foley Catheter with Temperature Sensor is a medical device that received FDA 510(k) clearance on 2020-10-15. It is manufactured by Deroyal Industries, Inc.. The 510(k) number is K200757.

When was Foley Catheter with Temperature Sensor approved by the FDA?

Foley Catheter with Temperature Sensor received FDA 510(k) clearance on 2020-10-15, under approval number K200757.

What company makes Foley Catheter with Temperature Sensor?

Foley Catheter with Temperature Sensor is manufactured by Deroyal Industries, Inc..

What is the FDA product code for Foley Catheter with Temperature Sensor?

The FDA product code for Foley Catheter with Temperature Sensor is EYC.

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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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