Name: Predicase
Price: 199 USD

K-number	K201699
Device name	Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor
Applicant	Surgical Instrument and Savings Inc (Dba Medline Renewal)
Product code	NLF
Device class	Class II
Decision date	Jul 22, 2020
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 Nellcor OxiMax SpO2 Sensor

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