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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Blood-Flow, Extravascular
510(k) Number K013939
Device Name JOSTRA FLOWPROBE FP-32E
Applicant
Jostra AG
478 Media Rd.
Oxford,  PA  19363
Applicant Contact KATHLEEN JOHNSON
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Regulation Number870.2120
Classification Product Code
DPT  
Date Received11/29/2001
Decision Date 12/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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