FDA 510(k)

D.O.R.C. Disposable Cryo Probe

N.º K: K160591 · 2017-01-23

SolicitanteDutch Ophthalmic Research Center International BV

Fecha de decisión2017-01-23

Código de productoHRN

Comité asesorOP

DecisiónSubstantially Equivalent

Resumen del dispositivo

D.O.R.C. Disposable Cryo Probe is the device name listed in this FDA 510(k) record. The listed applicant is Dutch Ophthalmic Research Center International BV. It received FDA 510(k) clearance on 2017-01-23 under 510(k) number K160591. The device is classified under product code HRN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the D.O.R.C. Disposable Cryo Probe?

D.O.R.C. Disposable Cryo Probe is a medical device that received FDA 510(k) clearance on 2017-01-23. The listed applicant is Dutch Ophthalmic Research Center International BV. The 510(k) number is K160591.

When did D.O.R.C. Disposable Cryo Probe receive FDA 510(k) clearance?

D.O.R.C. Disposable Cryo Probe received FDA 510(k) clearance on 2017-01-23, under 510(k) number K160591.

Who is the listed applicant for D.O.R.C. Disposable Cryo Probe?

The FDA 510(k) record lists Dutch Ophthalmic Research Center International BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D.O.R.C. Disposable Cryo Probe?

The FDA product code for D.O.R.C. Disposable Cryo Probe is HRN.

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Fuente oficial

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