Name: Predicase
Price: 199 USD

K-number	K970769
Device name	COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR
Applicant	Aristo Medical
Product code	DQA
Device class	Class II
Decision date	Aug 28, 1997
Decision	Substantially Equivalent
Regulation	870.2700

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Source

View the full FDA submission: accessdata.fda.gov

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COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR

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