Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
K-Number: K221845 · 2023-02-24
ApplicantBlue Sky Bio, LLC
Decision Date2023-02-24
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G is a medical device manufactured by Blue Sky Bio, LLC. It received FDA 510(k) clearance on 2023-02-24 under approval number K221845. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G?
Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G is a medical device that received FDA 510(k) clearance on 2023-02-24. It is manufactured by Blue Sky Bio, LLC. The 510(k) number is K221845.
When was Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G approved by the FDA?
Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G received FDA 510(k) clearance on 2023-02-24, under approval number K221845.
What company makes Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G?
Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G is manufactured by Blue Sky Bio, LLC.
What is the FDA product code for Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G?
The FDA product code for Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G is NXC.
Other Devices by Blue Sky Bio, LLC
Related Devices (Code: NXC)
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.