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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
510(k) Number K001388
Device Name DATA MASTER PERFUSION MONITORING SYSTEM
Applicant
DIDECO
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760 -4153
Applicant Contact ROSINA ROBINSON
Correspondent
DIDECO
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760 -4153
Correspondent Contact ROSINA ROBINSON
Regulation Number870.4330
Classification Product Code
DRY  
Date Received05/02/2000
Decision Date 07/28/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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