Name: Predicase
Price: 199 USD

K-number	K040507
Device name	TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H
Applicant	Taga Medical Technologies, Inc.
Product code	BTT
Device class	Class II
Decision date	Mar 4, 2004
Decision	Substantially Equivalent
Regulation	868.5450

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Source

View the full FDA submission: accessdata.fda.gov

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TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H

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