FDA Status of the Halimeter^®

Official Classification

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 Device Name:   HALIMETER HALITOSIS METER

Common/Generic Device Name:   LABORATORY EQUIPMENT

Classification Name:   EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

Device Class:   I

Product Code:   LXG

Regulation Number:   862.2050

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, Chatsworth, CA...

Owner/Operator:   INTERSCAN CORP.

Owner/Operator Number:   9051481

Registered Establishment Name:   INTERSCAN CORP.

Establishment Registration Number:   2032709

Date of Listing:   04/29/02

Listing Status:   Active

Establishment Operations:   Manufacturer

 

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.