Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor

Oximeter, Reprocessed

Surgical Instrument And Savings Inc (dba Medline ReNewal)

The following data is part of a premarket notification filed by Surgical Instrument And Savings Inc (dba Medline Renewal) with the FDA for Medline Renewal Reprocessed Nellcor Oximax Spo2 Sensor.

Pre-market Notification Details

Device IDK201699
510k NumberK201699
Device Name:Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor
ClassificationOximeter, Reprocessed
Applicant Surgical Instrument And Savings Inc (dba Medline ReNewal) 1500 NE Hemlock Ave Redmond,  OR  97756
ContactStephanie Boyle Mays
CorrespondentStephanie Boyle Mays
Surgical Instrument Service And Savings Inc (dba Medline ReN 1500 NE Hemlock Ave Redmond,  OR  97756
Product CodeNLF  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-22
Decision Date2020-07-22

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