Name: Predicase
Price: 199 USD

K-number	K130320
Device name	BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW
Applicant	Covidien
Product code	DQA
Device class	Class II
Decision date	Feb 4, 2014
Decision	Substantially Equivalent
Regulation	870.2700

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Source

View the full FDA submission: accessdata.fda.gov

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BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW

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