Name: Predicase
Price: 199 USD

K-number	K960251
Device name	COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR
Applicant	Aristo Medical Products, Inc.
Product code	DQA
Device class	Class II
Decision date	Mar 26, 1996
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 AND COMSAT REUSABLE FINGER SENSOR

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