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FDA 510(k)

Care Orchestrator Essence

K-Number: K183226 · 2019-10-18

ApplicantRespironics, Inc.
Decision Date2019-10-18
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Care Orchestrator Essence is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2019-10-18 under 510(k) number K183226. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Care Orchestrator Essence?

Care Orchestrator Essence is a medical device that received FDA 510(k) clearance on 2019-10-18. The listed applicant is Respironics, Inc.. The 510(k) number is K183226.

When did Care Orchestrator Essence receive FDA 510(k) clearance?

Care Orchestrator Essence received FDA 510(k) clearance on 2019-10-18, under 510(k) number K183226.

Who is the listed applicant for Care Orchestrator Essence?

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 Orchestrator Essence?

The FDA product code for Care Orchestrator Essence is BZD.

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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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