Name: Predicase
Price: 199 USD

K-number	K962781
Device name	COROMETRICS MODEL 510 AND 511 MONITOR
Applicant	Ge Medical Systems Information Technologies
Product code	BZQ
Device class	Class II
Decision date	Mar 6, 1997
Decision	Substantially Equivalent - Subject to Tracking Reg.
Regulation	868.2375

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Source

View the full FDA submission: accessdata.fda.gov

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COROMETRICS MODEL 510 AND 511 MONITOR

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