FDA Status of the Halimeter®

Official FDA Classification FDA

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
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, Simi Valley, CA…

Registered Establishment Name: INTERSCAN CORP.                                                                                               
Registered Establishment Number: 2032709
Owner/Operator: INTERSCAN CORPORATION
Owner/Operator Number: 9051481
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.