Name: Predicase
Price: 199 USD

K-number	K181624
Device name	Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line
Applicant	Oridion Medical 1987 , Ltd.
Product code	CCK
Device class	Class II
Decision date	Mar 22, 2019
Decision	Substantially Equivalent
Regulation	868.1400

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Source

View the full FDA submission: accessdata.fda.gov

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Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line

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