Name: Predicase
Price: 199 USD

K-number	K181738
Device name	Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors
Applicant	Surgical Instrument Service and Savings Inc (Dba Medline
Product code	DQA
Device class	Class II
Decision date	Mar 22, 2019
Decision	Substantially Equivalent
Regulation	870.2700

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Source

View the full FDA submission: accessdata.fda.gov

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Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors

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