Name: Predicase
Price: 199 USD

K-number	K942170
Device name	MODEL 511 INFANT MONITOR
Applicant	Ge Medical Systems Information Technologies
Product code	BZQ
Device class	Class II
Decision date	Jun 2, 1995
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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MODEL 511 INFANT MONITOR

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