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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Impedance
510(k) Number K021174
Device Name ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR
Applicant
Imagyn Surgical
8850 M-89
Richland,  MI  49083
Applicant Contact JULIE POWELL
Correspondent
Imagyn Surgical
8850 M-89
Richland,  MI  49083
Correspondent Contact JULIE POWELL
Regulation Number870.2770
Classification Product Code
DSB  
Date Received04/12/2002
Decision Date 04/29/2003
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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