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FDA 510(k)

Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor

N.º K: K201699 · 2020-07-22

SolicitanteSurgical Instrument and Savings Inc (Dba Medline Renewal)
Fecha de decisión2020-07-22
Código de productoNLF
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument and Savings Inc (Dba Medline Renewal). It received FDA 510(k) clearance on 2020-07-22 under 510(k) number K201699. The device is classified under product code NLF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor?

Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor is a medical device that received FDA 510(k) clearance on 2020-07-22. The listed applicant is Surgical Instrument and Savings Inc (Dba Medline Renewal). The 510(k) number is K201699.

When did Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor receive FDA 510(k) clearance?

Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor received FDA 510(k) clearance on 2020-07-22, under 510(k) number K201699.

Who is the listed applicant for Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor?

The FDA 510(k) record lists Surgical Instrument and Savings Inc (Dba Medline Renewal) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor?

The FDA product code for Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor is NLF.

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Dispositivos relacionados (Código: NLF)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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