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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K951369
Device Name EDM
Applicant
Deltex Medical
15825 Shady Grove Rd.
Suite 70
Rockville,  MD  20850
Applicant Contact GLENN A RAHMOELLER
Correspondent
Deltex Medical
15825 Shady Grove Rd.
Suite 70
Rockville,  MD  20850
Correspondent Contact GLENN A RAHMOELLER
Regulation Number870.2100
Classification Product Code
DPW  
Date Received03/27/1995
Decision Date 11/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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