FDA 510(k)

dS Small Extremity 16CH 1.5T Coil

Número K: K162863 · 2016-11-07

RequerenteInvivo Therapeutics Corporation

Data da decisão2016-11-07

Código do produtoMOS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

dS Small Extremity 16CH 1.5T Coil is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Therapeutics Corporation. It received FDA 510(k) clearance on 2016-11-07 under 510(k) number K162863. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the dS Small Extremity 16CH 1.5T Coil?

dS Small Extremity 16CH 1.5T Coil is a medical device that received FDA 510(k) clearance on 2016-11-07. The listed applicant is Invivo Therapeutics Corporation. The 510(k) number is K162863.

When did dS Small Extremity 16CH 1.5T Coil receive FDA 510(k) clearance?

dS Small Extremity 16CH 1.5T Coil received FDA 510(k) clearance on 2016-11-07, under 510(k) number K162863.

Who is the listed applicant for dS Small Extremity 16CH 1.5T Coil?

The FDA 510(k) record lists Invivo Therapeutics Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for dS Small Extremity 16CH 1.5T Coil?

The FDA product code for dS Small Extremity 16CH 1.5T Coil is MOS.

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