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FDA 510(k)

Perfectio LED infrared device

N.º K: K152332 · 2016-02-25

SolicitanteOmm Imports Inc Dba Zero Gravity
Fecha de decisión2016-02-25
Código de productoOHS
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Perfectio LED infrared device is the device name listed in this FDA 510(k) record. The listed applicant is Omm Imports Inc Dba Zero Gravity. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K152332. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Perfectio LED infrared device?

Perfectio LED infrared device is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is Omm Imports Inc Dba Zero Gravity. The 510(k) number is K152332.

When did Perfectio LED infrared device receive FDA 510(k) clearance?

Perfectio LED infrared device received FDA 510(k) clearance on 2016-02-25, under 510(k) number K152332.

Who is the listed applicant for Perfectio LED infrared device?

The FDA 510(k) record lists Omm Imports Inc Dba Zero Gravity as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Perfectio LED infrared device?

The FDA product code for Perfectio LED infrared device is OHS.

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Fuente oficial

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