FDA 510(k)

HICP200 Patient/Monitor Interconnect Cable

Número K: K161010 · 2016-10-20

RequerenteInnerspace Neuro Solutions, Inc.

Data da decisão2016-10-20

Código do produtoGWM

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

HICP200 Patient/Monitor Interconnect Cable is the device name listed in this FDA 510(k) record. The listed applicant is Innerspace Neuro Solutions, Inc.. It received FDA 510(k) clearance on 2016-10-20 under 510(k) number K161010. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HICP200 Patient/Monitor Interconnect Cable?

HICP200 Patient/Monitor Interconnect Cable is a medical device that received FDA 510(k) clearance on 2016-10-20. The listed applicant is Innerspace Neuro Solutions, Inc.. The 510(k) number is K161010.

When did HICP200 Patient/Monitor Interconnect Cable receive FDA 510(k) clearance?

HICP200 Patient/Monitor Interconnect Cable received FDA 510(k) clearance on 2016-10-20, under 510(k) number K161010.

Who is the listed applicant for HICP200 Patient/Monitor Interconnect Cable?

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

What is the FDA product code for HICP200 Patient/Monitor Interconnect Cable?

The FDA product code for HICP200 Patient/Monitor Interconnect Cable is GWM.

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