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 a medical device manufactured by Respironics, Inc.. It received FDA 510(k) clearance on 2019-10-18 under approval 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. It is manufactured by Respironics, Inc.. The 510(k) number is K183226.
When was Care Orchestrator Essence approved by the FDA?
Care Orchestrator Essence received FDA 510(k) clearance on 2019-10-18, under approval number K183226.
What company makes Care Orchestrator Essence?
Care Orchestrator Essence is manufactured by Respironics, Inc..
What is the FDA product code for Care Orchestrator Essence?
The FDA product code for Care Orchestrator Essence is BZD.
Other Devices by Respironics, Inc.
Related Devices (Code: BZD)
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.