MODEL PM3030


Device Classification Name

stimulator, nerve, transcutaneous, over-the-counter

510(k) Number K110068
Device Name MODEL PM3030
Applicant
OMRON HEALTHCARE, INC.
24301 woodsage drive
bonita springs, 
FL 
34134

Applicant Contact paul dryden
Correspondent
OMRON HEALTHCARE, INC.
24301 woodsage drive
bonita springs, 
FL 
34134

Correspodent Contact paul dryden
Regulation Number 882.5890
Classification Product Code
NUH  
Date Received 01/10/2011
Decision Date 12/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No