M4 MONITOR


Device Classification Name

monitor, blood-gas, on-line, cardiopulmonary bypass

510(k) Number K110957
Device Name M4 MONITOR
Applicant
SPECTRUM MEDICAL, LLP
cheltenham road east
gloucester, 

GB

gl2 9ql

Applicant Contact steve turner
Regulation Number 870.4330
Classification Product Code
DRY  
Date Received 04/05/2011
Decision Date 05/31/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No