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 the device name listed in this FDA 510(k) record. The listed applicant is Fresca Medical, Inc.. It received FDA 510(k) clearance on 2020-06-29 under 510(k) 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. The listed applicant is Fresca Medical, Inc.. The 510(k) number is K200698.
When did Somnera System receive FDA 510(k) clearance?
Somnera System received FDA 510(k) clearance on 2020-06-29, under 510(k) number K200698.
Who is the listed applicant for Somnera System?
The FDA 510(k) record lists Fresca Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Somnera System?
The FDA product code for Somnera System is 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.