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FDA 510(k), K160526, Masimo O3 Regional Oximeter System
FDA 510(k), K160526, Masimo O3 Regional Oximeter System
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$49.00 USD
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$49.00 USD
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510(K) Number: K160526
Device Name: Masimo O3 Regional Oximeter System
Manufacturer: MARGUERITE THOMLINSON
Device Classification Name: Oximeter, Tissue Saturation
Regulation Number: MUD
Classification Product Code: KXA
Date Received: 02/25/2016
Decision Date: 06/09/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Masimo O3 Regional Oximeter System
Manufacturer: MARGUERITE THOMLINSON
Device Classification Name: Oximeter, Tissue Saturation
Regulation Number: MUD
Classification Product Code: KXA
Date Received: 02/25/2016
Decision Date: 06/09/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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