THERATRODE


Device Classification Name

electrode, cutaneous

510(k) Number K112312
Device Name THERATRODE
Applicant
PHOENIX MEDICAL DEVICES, LLP
2458 alton parkway
irvine, 
CA 
92606

Applicant Contact jim klett
Correspondent
PHOENIX MEDICAL DEVICES, LLP
2458 alton parkway
irvine, 
CA 
92606

Correspodent Contact jim klett
Regulation Number 882.1320
Classification Product Code
GXY  
Date Received 08/11/2011
Decision Date 01/25/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No