SICAT OPTISLEEP
K-Number: K153291 · 2016-03-31
ApplicantSicat GmbH & Co. KG
Decision Date2016-03-31
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
SICAT OPTISLEEP is a medical device manufactured by Sicat GmbH & Co. KG. It received FDA 510(k) clearance on 2016-03-31 under approval number K153291. 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 SICAT OPTISLEEP?
SICAT OPTISLEEP is a medical device that received FDA 510(k) clearance on 2016-03-31. It is manufactured by Sicat GmbH & Co. KG. The 510(k) number is K153291.
When was SICAT OPTISLEEP approved by the FDA?
SICAT OPTISLEEP received FDA 510(k) clearance on 2016-03-31, under approval number K153291.
What company makes SICAT OPTISLEEP?
SICAT OPTISLEEP is manufactured by Sicat GmbH & Co. KG.
What is the FDA product code for SICAT OPTISLEEP?
The FDA product code for SICAT OPTISLEEP is LRK.
Other Devices by Sicat GmbH & Co. KG
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.