Name: Predicase
Price: 199 USD

K-number	K090840
Device name	VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.
Applicant	Ventlab Corp.
Product code	CAF
Device class	Class II
Decision date	Jun 25, 2009
Decision	Substantially Equivalent
Regulation	868.5630

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Source

View the full FDA submission: accessdata.fda.gov

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VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.

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