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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 K192860
Device Name Sapphire Infusion Pump, Sapphire administration sets
Applicant
Q Core Medical Ltd.
29 Yad Haruzim St.
Netanya,  IL 4250529
Applicant Contact Guy Mlechkovich
Correspondent
Z & B Enterprises, Inc.
12154 Darnestown Road, #236
Gaithersburg,  MD  20878
Correspondent Contact Rhona Shanker
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Codes
FPA   MRZ  
Date Received10/04/2019
Decision Date 11/19/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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