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510(k) K993245

CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM by Alba Critical Care, Ltd. — Product Code DYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1999
Date Received
September 28, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Flow Directed
Device Class
Class II
Regulation Number
870.1240
Review Panel
CV
Submission Type

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