In accordance with Interscan’s 513(g) request for classification, the device is exempt from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act.
The Halimeter® is classified as follows:
|Proprietary Name:||HALIMETER HALITOSIS METER|
|Classification Name:||EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE|
|Medical Specialty:||Clinical Chemistry|
Registration Of Device Establishment
In accordance with Form FDA 2891, as issued by the US Department of Health and Human Services/Public Health Service/Food and Drug Administration – Center for Devices and Radiological Health, Rockville, MD, as issued to Interscan Corporation, Simi Valley, CA…
|Registered Establishment Name:||INTERSCAN CORP.|
|Registered Establishment Number:||2032709|
|Date of Listing:||04/29/02|
Foreign Customers and Dealers PLEASE NOTE
Notarized and officially sealed “Certificate To Foreign Government” documents, attesting that the Halimeter® may be marketed in, and legally exported from the United States, are available upon request. Normally, this document is only required the first time an instrument is exported to the country in question.
For further information on FDA matters, or other regulatory issues, please contact us.