CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS


Device Classification Name

electrocardiograph

510(k) Number K072449
Device Name CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS
Applicant
WELCH ALLYN, INC.
4341 state st. rd.
p.o. box 220
skaneateles falls, 
NY 
13153 -0220

Applicant Contact john sawyer
Correspondent
WELCH ALLYN, INC.
4341 state st. rd.
p.o. box 220
skaneateles falls, 
NY 
13153 -0220

Correspodent Contact john sawyer
Regulation Number 870.2340
Classification Product Code
DPS  
Subsequent Product Code
BZG  
Date Received 08/31/2007
Decision Date 11/29/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No