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FDA 510(k)

Care Cycle Connect Application

K-Number: K161411 · 2017-02-17

ApplicantRespironics, Inc.
Decision Date2017-02-17
Product CodeMOD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Care Cycle Connect Application is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2017-02-17 under 510(k) 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. The listed applicant is Respironics, Inc.. The 510(k) number is K161411.

When did Care Cycle Connect Application receive FDA 510(k) clearance?

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

Who is the listed applicant for Care Cycle Connect Application?

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

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

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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