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FDA 510(k)

Care Cycle Connect Application

K-Number: K161411 · 2017-02-17

Decision Date2017-02-17
Product CodeMOD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Care Cycle Connect Application is a medical device manufactured by Respironics, Inc.. It received FDA 510(k) clearance on 2017-02-17 under approval number K161411. The device is classified under product code MOD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Care Cycle Connect Application?

Care Cycle Connect Application is a medical device that received FDA 510(k) clearance on 2017-02-17. It is manufactured by Respironics, Inc.. The 510(k) number is K161411.

When was Care Cycle Connect Application approved by the FDA?

Care Cycle Connect Application received FDA 510(k) clearance on 2017-02-17, under approval number K161411.

What company makes Care Cycle Connect Application?

Care Cycle Connect Application is manufactured by Respironics, Inc..

What is the FDA product code for Care Cycle Connect Application?

The FDA product code for Care Cycle Connect Application is MOD.

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Official Source

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