Hello my name is Richard Flores, and represent Noraxon U.S.A., Inc. I am the
Production/Quality Control Engineer. We manufacturer Surface Electromyography
equipment.
I am requesting some information that I have been able to obtain for quite
some time now. What I need is some information on where can I obtain data
(e.g. books manuals etc..) on Guidelines on 510k submittal for FDA approval on
Class I medical Devices. In particular Surface EMG.
If possible examples of previously approved 510k's would help.
We currently follow and practice Good Quality Systems requirements. What I
need to do is begin to package together a 510k submittal application,and
specification etc...Any help would be greatly appreciated.
If possible CE requirements for the above listing is also on my list. Please
advise.
e-mail at FloresRch@aol.com
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Production/Quality Control Engineer. We manufacturer Surface Electromyography
equipment.
I am requesting some information that I have been able to obtain for quite
some time now. What I need is some information on where can I obtain data
(e.g. books manuals etc..) on Guidelines on 510k submittal for FDA approval on
Class I medical Devices. In particular Surface EMG.
If possible examples of previously approved 510k's would help.
We currently follow and practice Good Quality Systems requirements. What I
need to do is begin to package together a 510k submittal application,and
specification etc...Any help would be greatly appreciated.
If possible CE requirements for the above listing is also on my list. Please
advise.
e-mail at FloresRch@aol.com
---------------------------------------------------------------
To unsubscribe send SIGNOFF BIOMCH-L to LISTSERV@nic.surfnet.nl
For information and archives: http://isb.ri.ccf.org/biomch-l
---------------------------------------------------------------