FDA 510(k)

Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)

Número K: K202100 · 2020-10-19

Data da decisão2020-10-19

Código do produtoPLV

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) is the device name listed in this FDA 510(k) record. The listed applicant is Neocis, Inc.. It received FDA 510(k) clearance on 2020-10-19 under 510(k) number K202100. The device is classified under product code PLV. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)?

Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) is a medical device that received FDA 510(k) clearance on 2020-10-19. The listed applicant is Neocis, Inc.. The 510(k) number is K202100.

When did Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) receive FDA 510(k) clearance?

Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) received FDA 510(k) clearance on 2020-10-19, under 510(k) number K202100.

Who is the listed applicant for Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)?

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

What is the FDA product code for Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)?

The FDA product code for Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) is PLV.

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Fonte oficial

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