DELTEX MEDICAL CARDIOQ EDM


Device Classification Name

flowmeter, blood, cardiovascular

510(k) Number K111542
Device Name DELTEX MEDICAL CARDIOQ EDM
Applicant
DELTEX MEDICAL LIMITED
biopark, broadwater road
welwyn garden city
hertsfordshire, 

GB

al7 3ax

Applicant Contact neil r armstrong
Correspondent
DELTEX MEDICAL LIMITED
biopark, broadwater road
welwyn garden city
hertsfordshire, 

GB

al7 3ax

Correspodent Contact neil r armstrong
Regulation Number 870.2100
Classification Product Code
DPW  
Subsequent Product Codes
DPT   DSA  
Date Received 06/02/2011
Decision Date 10/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No