Somnera System
K-Number: K200698 · 2020-06-29
ApplicantFresca Medical, Inc.
Decision Date2020-06-29
Product CodeQBY
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Somnera System is a medical device manufactured by Fresca Medical, Inc.. It received FDA 510(k) clearance on 2020-06-29 under approval number K200698. The device is classified under product code QBY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Somnera System?
Somnera System is a medical device that received FDA 510(k) clearance on 2020-06-29. It is manufactured by Fresca Medical, Inc.. The 510(k) number is K200698.
When was Somnera System approved by the FDA?
Somnera System received FDA 510(k) clearance on 2020-06-29, under approval number K200698.
What company makes Somnera System?
Somnera System is manufactured by Fresca Medical, Inc..
What is the FDA product code for Somnera System?
The FDA product code for Somnera System is QBY.
Related Devices (Code: QBY)
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.