Sunrise
K-Number: K222262 · 2022-12-22
ApplicantSunrise SA
Decision Date2022-12-22
Product CodeQRS
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Sunrise is a medical device manufactured by Sunrise SA. It received FDA 510(k) clearance on 2022-12-22 under approval number K222262. The device is classified under product code QRS. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sunrise?
Sunrise is a medical device that received FDA 510(k) clearance on 2022-12-22. It is manufactured by Sunrise SA. The 510(k) number is K222262.
When was Sunrise approved by the FDA?
Sunrise received FDA 510(k) clearance on 2022-12-22, under approval number K222262.
What company makes Sunrise?
Sunrise is manufactured by Sunrise SA.
What is the FDA product code for Sunrise?
The FDA product code for Sunrise is QRS.
Other Devices by Sunrise SA
Related Devices (Code: QRS)
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.