MCKESSON CARDIOLOGY HEMO

Device Classification Name

monitor,physiological,patient(without arrhythmia detection or alarms)

510(k) Number K131497
Device Name MCKESSON CARDIOLOGY HEMO
Applicant
MCKESSON ISRAEL LTD.
5995 windward parkway
alpharetta, 
GA 
30005

Applicant Contact paul sumner
Correspondent
MCKESSON ISRAEL LTD.
5995 windward parkway
alpharetta, 
GA 
30005

Correspodent Contact paul sumner
Regulation Number 870.2300
Classification Product Code
MWI  
Subsequent Product Code
DQK  
Date Received 05/24/2013
Decision Date 12/05/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls