K-number	K851632
Device name	PCX-100 PATIENT INPUT LEADWIRE
Applicant	Eaton Medical Group
Product code	DRW
Device class	Class II
Decision date	Nov 8, 1985
Decision	Substantially Equivalent
Regulation	870.2350

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View the full FDA submission: accessdata.fda.gov

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PCX-100 PATIENT INPUT LEADWIRE

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