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FDA 510(k)

Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX

K-Number: K232653 · 2024-04-03

Decision Date2024-04-03
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX is a medical device manufactured by Blue Sky Bio, LLC. It received FDA 510(k) clearance on 2024-04-03 under approval number K232653. 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 Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX?

Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX is a medical device that received FDA 510(k) clearance on 2024-04-03. It is manufactured by Blue Sky Bio, LLC. The 510(k) number is K232653.

When was Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX approved by the FDA?

Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX received FDA 510(k) clearance on 2024-04-03, under approval number K232653.

What company makes Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX?

Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX is manufactured by Blue Sky Bio, LLC.

What is the FDA product code for Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX?

The FDA product code for Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX is NXC.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.