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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K242660
Device Name Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets
Applicant
Zevex, Inc.
4314 Zevex Park Ln.,
Salt Lake City,  UT  84123
Applicant Contact Santosh Bhagat
Correspondent
Zevex, Inc.
4314 Zevex Park Ln.,
Salt Lake City,  UT  84123
Correspondent Contact Santosh Bhagat
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
FPA  
Date Received09/04/2024
Decision Date 10/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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