[optimal] Re: FDA important info
- From: m.whitby@xxxxxxxxxxxxxxxxx
- To: optimal@xxxxxxxxxxxxx
- Date: Thu, 3 Nov 2011 08:06:56 -0800
It did not sit well with me either.
It is interesting that he is so bold with his information, yet erroneously
uses the term "approved" which is incorrect. Devices are cleared by the
FDA
Marianne Whitby
Check out our new website! http://www.meditec.zeiss.com/Cirrus
and Visit Eye on OCT An On-line News and Education Resource
http://www.oct.zeiss.com/
________
Carl Zeiss Meditec Inc.
Senior Marketing Manager
Retinal OCT
5160 Hacienda Drive
Dublin, CA 94568
Marianne Whitby
Phone: +1 925.557.4447
Cell: +1 925.997.0056
Fax: +1 925.557.4675
mailto:m.whitby@xxxxxxxxxxxxxxxxx
http://www.meditec.zeiss.com
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Lon Dowell
<lon_dowell@yahoo
.com> To
Sent by: "optimal@xxxxxxxxxxxxx"
optimal-bounce@fr <optimal@xxxxxxxxxxxxx>
eelists.org cc
Subject
11/03/2011 08:58 [optimal] Re: FDA important info
AM
Please respond to
optimal@freelists
.org
It's been a while since I visited OPTIMAL. Did not realize it has turned
into yet another mechanisim for advertisement...
All the best,
Lon
Lon Dowell
http://www.linkedin.com/pub/2/A13/69A
From: Dale Brodsky <dale.brodsky@xxxxxxxxx>
To: optimal@xxxxxxxxxxxxx
Sent: Thursday, November 3, 2011 8:01 AM
Subject: [optimal] FDA important info
Did you know...
Medicare requires FDA approved devices for payment and
FDA reports all device approvals to CMS?
Medicare Benefit Policy Manual, Chapter 14 - Medical Devices, sections 10 &
80 https://www.cms.gov/manuals/downloads/bp102c14.pdf
******
FUNDUS PHOTO has US FDA 510(k) clearance
We are the one of the ONLY ophthalmic digital imaging provider in this
segment* to achieve the highest level of quality, safety and performance
the FDA & ISO require** and our customers demand.
*Segment refers to using off-the-shelf digital SLR cameras.
**All devices, attachments or software used for diagnosis and/or treatment
are required to have FDA clearance for commercial distribution in the US.
Look up any company at the FDA website
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
Topcon, Zeiss, Escalon, OIS, Kowa, Nidek, Canon and Fundus Photo all have
FDA clearance and may legally market their imaging products (hardware and
software) in the US.
Dale Brodsky
President - Fundus Photo, LLC - digital imaging for fundus cameras - FDA
Approved!
Owner - St. Louis Ophthalmic Equipment Company - in our 20th year!
3015 Locust Street St. Louis, MO 63103 USA
314.533.6000 fax 314.534.6000 Mobile 314.406.3600
Visit our websites at http://www.stleye.com and http://www.fundusphoto.com
email - dale.brodsky@xxxxxxxxx
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