FDA Registration

 

BioMeridian operates under Food and Drug Administration 510(K) number K993824 for Meridian Stress Assessment. The intended use of BioMeridian devices is for the measurement of Galvanic Skin Response. BioMeridian is a registered establishment of the Food and Drug Administration. Registration number 1723429.
 

Registration Summary
   
Device Classification Name Device, Galvanic Skin Response Measurement
Regulation Number 882.1540
510(K) Number K993824
Device Name MSAS Professional
Applicant BioMeridian, Int.
12411 South 265 W.  Ste. F.
Draper, UT 84020
Contact Gene Swift
Product Code GZO
Date Received 11/12/1999
Decision Date 01/20/2000
Decision Substantially Equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Statement/Summary/Purged Status Summary/ Purged 510 (K)
Type Special
Reviewed By Third Party No
Expedited Review No
         
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Upcoming Events
 
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Study Groups NEW
BioMeridian study groups are informal events, hosted by a BioMeridian representative, designed to ensure access to local, hands-on support, for our customers after they have received basic training. The study groups are held regularly throughout the country to ensure each of our customers has the chance to receive continued support and the opportunity to meet other practitioners in the field. These events are for practitioners (or staff) only and are not appropriate for the general public or patients.
Lino Lakes, MN
May 19
Country Inn & Suites
725 Town Center
Lino Lakes, MN 55014
Please call 763-746-9500 for directions.
Orange County, CA
May 21
Hyatt Regency Orange County
11999 Harbour Blvd.
Garden Grove, CA 92840
714.750.1234
Orange County, CA
May 21
Hyatt Regency Orange County
11999 Harbour Blvd.
Garden Grove, CA 92840
714.750.1234
Click here to view more events...
 
 
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