FDA 510(k)

ERBE ESU Model VIO dV with Accessories

N.º K: K150364 · 2016-05-05

Fecha de decisión2016-05-05

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

ERBE ESU Model VIO dV with Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Erbe Elektromedizin GmbH. It received FDA 510(k) clearance on 2016-05-05 under 510(k) number K150364. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ERBE ESU Model VIO dV with Accessories?

ERBE ESU Model VIO dV with Accessories is a medical device that received FDA 510(k) clearance on 2016-05-05. The listed applicant is Erbe Elektromedizin GmbH. The 510(k) number is K150364.

When did ERBE ESU Model VIO dV with Accessories receive FDA 510(k) clearance?

ERBE ESU Model VIO dV with Accessories received FDA 510(k) clearance on 2016-05-05, under 510(k) number K150364.

Who is the listed applicant for ERBE ESU Model VIO dV with Accessories?

The FDA 510(k) record lists Erbe Elektromedizin GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ERBE ESU Model VIO dV with Accessories?

The FDA product code for ERBE ESU Model VIO dV with Accessories is GEI.

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Otros registros que enlistan a Erbe Elektromedizin GmbH como solicitante

K261806ERBECRYO 2 Cryosurgical Unit and Accessories K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe K253915MOVIVA® Hybrid Ablation Probe K251108Erbe ESU Model VIO® 3n with Accessories K243120HybridAPC probe K243451FiAPC plus probes

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Fuente oficial

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