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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
510(k) Number K083735
Device Name ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS
Applicant
Medtechs, LLC
111 Beaver Dam Run
Durhan,  NC  27703
Applicant Contact MEGHAN ATH
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.2780
Classification Product Code
JOM  
Subsequent Product Code
DPS  
Date Received12/16/2008
Decision Date 02/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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