SML-OSA2 Appliances
K-Number: K162816 · 2017-07-27
ApplicantSelane Products, Inc.
Decision Date2017-07-27
Product CodeLQZ
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
SML-OSA2 Appliances is a medical device manufactured by Selane Products, Inc.. It received FDA 510(k) clearance on 2017-07-27 under approval number K162816. The device is classified under product code LQZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SML-OSA2 Appliances?
SML-OSA2 Appliances is a medical device that received FDA 510(k) clearance on 2017-07-27. It is manufactured by Selane Products, Inc.. The 510(k) number is K162816.
When was SML-OSA2 Appliances approved by the FDA?
SML-OSA2 Appliances received FDA 510(k) clearance on 2017-07-27, under approval number K162816.
What company makes SML-OSA2 Appliances?
SML-OSA2 Appliances is manufactured by Selane Products, Inc..
What is the FDA product code for SML-OSA2 Appliances?
The FDA product code for SML-OSA2 Appliances is LQZ.
Related Devices (Code: LQZ)
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.