510(k) K040802

HEMOSONIC 200HEMODYNAMIC MONITOR by Arrow Intl., Inc. — Product Code DPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2004
Date Received
March 29, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Propoxyphene
Device Class
Class II
Regulation Number
862.3700
Review Panel
TX
Submission Type