Respire Clear
K-Number: K214096 · 2022-05-31
ApplicantRespire Medical, LLC
Decision Date2022-05-31
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Respire Clear is a medical device manufactured by Respire Medical, LLC. It received FDA 510(k) clearance on 2022-05-31 under approval number K214096. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Respire Clear?
Respire Clear is a medical device that received FDA 510(k) clearance on 2022-05-31. It is manufactured by Respire Medical, LLC. The 510(k) number is K214096.
When was Respire Clear approved by the FDA?
Respire Clear received FDA 510(k) clearance on 2022-05-31, under approval number K214096.
What company makes Respire Clear?
Respire Clear is manufactured by Respire Medical, LLC.
What is the FDA product code for Respire Clear?
The FDA product code for Respire Clear is LRK.
Related Devices (Code: LRK)
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.