Name: Predicase
Price: 199 USD

K-number	K014294
Device name	MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414
Applicant	Medical Data Electronics
Product code	DQA
Device class	Class II
Decision date	Jan 25, 2002
Decision	Substantially Equivalent
Regulation	870.2700

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Source

View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414

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