Ventilator, Non-continuous (Respirator)
K-Number: K201439 · 2020-09-25
ApplicantRespironics, Inc.
Decision Date2020-09-25
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Ventilator, Non-continuous (Respirator) is a medical device manufactured by Respironics, Inc.. It received FDA 510(k) clearance on 2020-09-25 under approval number K201439. 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 Ventilator, Non-continuous (Respirator)?
Ventilator, Non-continuous (Respirator) is a medical device that received FDA 510(k) clearance on 2020-09-25. It is manufactured by Respironics, Inc.. The 510(k) number is K201439.
When was Ventilator, Non-continuous (Respirator) approved by the FDA?
Ventilator, Non-continuous (Respirator) received FDA 510(k) clearance on 2020-09-25, under approval number K201439.
What company makes Ventilator, Non-continuous (Respirator)?
Ventilator, Non-continuous (Respirator) is manufactured by Respironics, Inc..
What is the FDA product code for Ventilator, Non-continuous (Respirator)?
The FDA product code for Ventilator, Non-continuous (Respirator) 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.