Apogee
K-Number: K200401 · 2020-11-14
ApplicantIncoba Ltd D/B/A Dynaris
Decision Date2020-11-14
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Apogee is a medical device manufactured by Incoba Ltd D/B/A Dynaris. It received FDA 510(k) clearance on 2020-11-14 under approval number K200401. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Apogee?
Apogee is a medical device that received FDA 510(k) clearance on 2020-11-14. It is manufactured by Incoba Ltd D/B/A Dynaris. The 510(k) number is K200401.
When was Apogee approved by the FDA?
Apogee received FDA 510(k) clearance on 2020-11-14, under approval number K200401.
What company makes Apogee?
Apogee is manufactured by Incoba Ltd D/B/A Dynaris.
What is the FDA product code for Apogee?
The FDA product code for Apogee is NFB.
Related Devices (Code: NFB)
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.