510(k) K083735

ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS by Medtechs, LLC — Product Code JOM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2009
Date Received
December 16, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class
Class II
Regulation Number
870.2780
Review Panel
CV
Submission Type