Respire Pink Series with DentiTrac
K-Number: K170692 · 2017-05-26
ApplicantRespire Medical Holding
Decision Date2017-05-26
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Respire Pink Series with DentiTrac is a medical device manufactured by Respire Medical Holding. It received FDA 510(k) clearance on 2017-05-26 under approval number K170692. 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 Series with DentiTrac?
Respire Pink Series with DentiTrac is a medical device that received FDA 510(k) clearance on 2017-05-26. It is manufactured by Respire Medical Holding. The 510(k) number is K170692.
When was Respire Pink Series with DentiTrac approved by the FDA?
Respire Pink Series with DentiTrac received FDA 510(k) clearance on 2017-05-26, under approval number K170692.
What company makes Respire Pink Series with DentiTrac?
Respire Pink Series with DentiTrac is manufactured by Respire Medical Holding.
What is the FDA product code for Respire Pink Series with DentiTrac?
The FDA product code for Respire Pink Series with DentiTrac 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.