Respire Pink AT (Hard, Hard/Soft, EF)
K-Number: K192127 · 2020-02-05
ApplicantRespire Medical Holdings
Decision Date2020-02-05
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Respire Pink AT (Hard, Hard/Soft, EF) is a medical device manufactured by Respire Medical Holdings. It received FDA 510(k) clearance on 2020-02-05 under approval number K192127. 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 Pink AT (Hard, Hard/Soft, EF)?
Respire Pink AT (Hard, Hard/Soft, EF) is a medical device that received FDA 510(k) clearance on 2020-02-05. It is manufactured by Respire Medical Holdings. The 510(k) number is K192127.
When was Respire Pink AT (Hard, Hard/Soft, EF) approved by the FDA?
Respire Pink AT (Hard, Hard/Soft, EF) received FDA 510(k) clearance on 2020-02-05, under approval number K192127.
What company makes Respire Pink AT (Hard, Hard/Soft, EF)?
Respire Pink AT (Hard, Hard/Soft, EF) is manufactured by Respire Medical Holdings.
What is the FDA product code for Respire Pink AT (Hard, Hard/Soft, EF)?
The FDA product code for Respire Pink AT (Hard, Hard/Soft, EF) 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.