Name: Predicase
Price: 199 USD

K-number	K961972
Device name	MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR
Applicant	Aequitron Medical, Inc.
Product code	BZQ
Device class	Class II
Decision date	Apr 18, 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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MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR

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