SPAULDING IQ ELECTROCARDIOGRAPH


Device Classification Name

electrocardiograph

510(k) Number K110065
Device Name SPAULDING IQ ELECTROCARDIOGRAPH
Applicant
SPAULDING CLINICAL RESEARCH, LLC
525 s. silverbrook drive
west bend, 
WI 
53095

Applicant Contact paul schultz
Correspondent
SPAULDING CLINICAL RESEARCH, LLC
525 s. silverbrook drive
west bend, 
WI 
53095

Correspodent Contact paul schultz
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 01/10/2011
Decision Date 03/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No