510(k) K083735

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

K083735 is an FDA 510(k) premarket notification submitted by Medtechs, LLC for the device "ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS". The FDA issued a decision of Substantially Equivalent on February 18, 2009. The device falls under product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic), a Class II device regulated under 21 CFR 870.2780. Medtechs, LLC has at least 1 other 510(k) clearance on record.