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Selson Clinics Neurology
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Selson Clinics Neurology
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Company Info
Selson Clinics Neurology [United States]
Country/Region: United States
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Inquiry about Digital EEG [United States]
| Update Time: | 2011-08-13 |
|---|---|
| Valid to: | Never Expired |
| Detailed Description: | August. 11. 2011 Dear Sir/Madam, Over the past 6 weeks I tried, unsuccessfully to purchase a Digital EEG (16-32 channels) and Brain Mapping machine. My intent was to purchase a Digital EEG and Brain Mapping machine, and to use this machine to evaluate patients with epilepsy, in my Neurodiagnostic Lab at Selson Clinics Neurology. It was also my plan, to introduce this Digital EEG and Brain Mapping machine to the other members of my branch of the American Epilepsy Society. To date, I have a count of fifty (50) Neurophysiologists/Epileptologists who are each interested in purchasing the same Digital EEG and Brain Mapping machine, once I can demonstrate that machine's effective operability. As a result of my search to purchase a Digital EEG and Brain Mapping machine from Made-in-China.com website, I learned that no company in China has a FDA approved Digital EEG and Brain Mapping machine. The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has approved my registration and listing information identifying me as the Official Correspondent for the medical device facility; Selson Clinics Neurology. Therefore, it is my plan to purchase a Digital EEG and Brain Mapping machine and have it shipped to me in the United States. I will then conduct EEG analysis on 100 patients over a 6 week period, to ensure that the Digital EEG and Brain Mapping machine meets the International Federation of Clinical Neurophysiology (IFCN) standards for digital recording of clinical EEG [Encephalopathy and Clinical Neurophysiology 106 (1998) pp 259-261]. Once the Digital EEG and Brain Mapping machine is shown to be effective in acquiring, storing and displaying EEG data, then I will apply to the FDA for a Section 501 (k) premarket notification of intent to market the Digital EEG and Brain Mapping machine in the United States of America. This will then allow other members of the American Epilepsy Society and the Neurodiagnostic Society to individually purchase the same Digital EEG and Brain Mapping machine from the same manufacturer in China, or to make arrangements to purchase as a group 50-100 Digital EEG and Brain Mapping machines. All that is required, is for a Digital EEG and Brain Mapping machine manufacturer in China to sell and successfully ship to me a Digital EEG and Brain Mapping machine with 16-32 channels. I will then take care of the FDA certification, after using that Digital EEG and Brain Mapping machine as stated above. The market in the United States, for a solid, cost-effective Digital EEG and Brain Mapping machine is enormous. This correspondence is sent to all manufactures of Digital EEG and Brain Mapping machine with 16-32 channels on the Made-in-China.com website. Sincerely, Selwyn-Lloyd McPherson, MB,BS, MD Neurologist/Clinical Neurophysiologist/Epileptologist SELSON CLINICS NEUROLOGY One Park West Blvd. Suite 320, |
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Contact Details
Mr. Selwyn-Lloyd McPherson MBBS M.D.
