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PMA de la FDA

Optical diagnostic device for melanoma detection

Número de PMA: P090012 · 2016-08-18

SolicitanteStrata Skin Sciences, Inc.
Fecha de decisión2016-08-18
Número PMAP090012
Código de productoOYD
Clase del dispositivoClase 2
Especialidad médicaG
Número de regulación21 CFR 8
Comité asesorSU

Resumen del dispositivo

Optical diagnostic device for melanoma detection is the device name listed in this FDA 510(k) record. The listed applicant is Strata Skin Sciences, Inc.. It received FDA 510(k) clearance on 2016-08-18. The device is classified under product code OYD. It was reviewed by the SU advisory panel.

Preguntas frecuentes

What is the Optical diagnostic device for melanoma detection?

Optical diagnostic device for melanoma detection is a medical device that received FDA 510(k) clearance on 2016-08-18. The listed applicant is Strata Skin Sciences, Inc..

When did Optical diagnostic device for melanoma detection receive FDA 510(k) clearance?

The clearance date for Optical diagnostic device for melanoma detection can be found in the official FDA records.

Who is the listed applicant for Optical diagnostic device for melanoma detection?

The FDA 510(k) record lists Strata Skin Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optical diagnostic device for melanoma detection?

The FDA product code for Optical diagnostic device for melanoma detection is OYD.

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Fuente oficial

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