Name: Predicase
Price: 199 USD

K-number	K121669
Device name	WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)
Applicant	Cincinnati Sub-Zero Products, Inc.
Product code	DWJ
Device class	Class II
Decision date	Jul 3, 2012
Decision	Substantially Equivalent
Regulation	870.5900

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Source

View the full FDA submission: accessdata.fda.gov

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WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)

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