FDA 510(k)

CONTINUUM PACS

N.º K: K200385 · 2020-03-16

SolicitanteIntegrated Ophthalmic Systems, Inc.

Fecha de decisión2020-03-16

Código de productoNFJ

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

CONTINUUM PACS is the device name listed in this FDA 510(k) record. The listed applicant is Integrated Ophthalmic Systems, Inc.. It received FDA 510(k) clearance on 2020-03-16 under 510(k) number K200385. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CONTINUUM PACS?

CONTINUUM PACS is a medical device that received FDA 510(k) clearance on 2020-03-16. The listed applicant is Integrated Ophthalmic Systems, Inc.. The 510(k) number is K200385.

When did CONTINUUM PACS receive FDA 510(k) clearance?

CONTINUUM PACS received FDA 510(k) clearance on 2020-03-16, under 510(k) number K200385.

Who is the listed applicant for CONTINUUM PACS?

The FDA 510(k) record lists Integrated Ophthalmic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTINUUM PACS?

The FDA product code for CONTINUUM PACS is NFJ.

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Fuente oficial

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