K-number	K201620
Device name	Luna® G3 BPAP 25A
Applicant	3B Medical, Inc.
Product code	BZD
Device class	Class II
Decision date	Jan 29, 2021
Decision	Substantially Equivalent
Regulation	868.5905

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Source

View the full FDA submission: accessdata.fda.gov

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Luna® G3 BPAP 25A

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