Name: Predicase
Price: 199 USD

K-number	K232653
Device name	Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX
Applicant	Blue Sky Bio, LLC
Product code	NXC
Device class	Class II
Decision date	Apr 3, 2024
Decision	Substantially Equivalent
Regulation	872.5470

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.