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FDA 510(k)

Care Orchestrator

K-Number: K181053 · 2019-01-04

ApplicantRespironics, Inc.
Decision Date2019-01-04
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Care Orchestrator is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2019-01-04 under 510(k) number K181053. 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?

Care Orchestrator is a medical device that received FDA 510(k) clearance on 2019-01-04. The listed applicant is Respironics, Inc.. The 510(k) number is K181053.

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

Care Orchestrator received FDA 510(k) clearance on 2019-01-04, under 510(k) number K181053.

Who is the listed applicant for Care Orchestrator?

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?

The FDA product code for Care Orchestrator 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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