PureSleep (OTC use)
K-Number: K190058 · 2019-04-11
ApplicantSleep Science Partners, Inc.
Decision Date2019-04-11
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
PureSleep (OTC use) is a medical device manufactured by Sleep Science Partners, Inc.. It received FDA 510(k) clearance on 2019-04-11 under approval number K190058. 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 PureSleep (OTC use)?
PureSleep (OTC use) is a medical device that received FDA 510(k) clearance on 2019-04-11. It is manufactured by Sleep Science Partners, Inc.. The 510(k) number is K190058.
When was PureSleep (OTC use) approved by the FDA?
PureSleep (OTC use) received FDA 510(k) clearance on 2019-04-11, under approval number K190058.
What company makes PureSleep (OTC use)?
PureSleep (OTC use) is manufactured by Sleep Science Partners, Inc..
What is the FDA product code for PureSleep (OTC use)?
The FDA product code for PureSleep (OTC use) 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.