SEER LIGHT COMPACT DIGITAL HOLTER RECORDER


Device Classification Name

electrocardiograph,ambulatory(without analysis)

510(k) Number K021470
Device Name SEER LIGHT COMPACT DIGITAL HOLTER RECORDER
Original Applicant
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
8200 west tower ave.
milwaukee, 
WI 
53223

Original Contact lisa lee michels
Regulation Number 870.2800
Classification Product Code
MWJ  
Date Received 05/08/2002
Decision Date 11/14/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No