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 Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 870.2780
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/16/2008 |
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
|
|
|