Name: Predicase
Price: 199 USD

K-number	K122857
Device name	HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100
Applicant	Pegasus Research Corp.
Product code	CAF
Device class	Class II
Decision date	Nov 7, 2012
Decision	Substantially Equivalent
Regulation	868.5630

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Source

View the full FDA submission: accessdata.fda.gov

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HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100

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