510(k) K101115

ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150 by Mortara Instrument, Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2010
Date Received
April 21, 2010
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type