VERMED A10021 RESTING EKG TAB ELECTRODE


Device Classification Name

electrode, electrocardiograph

510(k) Number K030073
Device Name VERMED A10021 RESTING EKG TAB ELECTRODE
Original Applicant
VERMONT MEDICAL, INC.
industrial park
bellows falls, 
VT 
05101

Original Contact marc fillion
Regulation Number 870.2360
Classification Product Code
DRX  
Date Received 01/08/2003
Decision Date 03/28/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No