Tue Aug 23 2016

Incorrect Statement?

The statement above "This product is not sold in the U.S by the manufacturer" is either not true or we were sold a restricted device. We have purchased from NK and still use the AG-920RA module for our Surgery site.

If it should not have been sold in the US then I would appreciate the info.

Thanks

KP


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Tue Aug 23 2016Reply from AJ_Diaz
avatar placemark

It looks like this product was only to be circulated in Germany. Every search I find with a connection to this device that has a Nihon Kohden webpage attached to it is a .de domain which is the domain extension for Germany.

Might want to get these replaced. You won't be able to buy parts from Nihon Kohden for this device. Third party vendors, maybe but not OEM.


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Wed Aug 24 2016Reply from MedWrench MM
MedWrench MM

Via my contact at Nihon Kohden:

The better verbiage for the AG-920RA would be discontinued.  It has been replaced by the GF-210RA.

http://us.nihonkohden.com/products/gf-210ra/

The AG-920RA was cleared to market in the US under 510k # K020046

The GF-210RA was cleared to market in the US under 510k # K110594 in 2011


Jonathan F. Payne,
Media Manager @ MedWrench,
866-989-7057,
Jpayne@MedWrench.com
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