Sapphire Infusion Pump, Sapphire Administration Sets

Pump, Infusion

Q Core Medical Ltd.

The following data is part of a premarket notification filed by Q Core Medical Ltd. with the FDA for Sapphire Infusion Pump, Sapphire Administration Sets.

Pre-market Notification Details

• Device ID: K192860
• 510k Number: K192860
• Device Name: Sapphire Infusion Pump, Sapphire Administration Sets
• Classification: Pump, Infusion
• Applicant: Q Core Medical Ltd. 29 Yad Haruzim St. Netanya, IL 4250529
• Contact: Guy Mlechkovich
• Correspondent: Rhona Shanker; Z & B Enterprises, Inc. 12154 Darnestown Road, #236 Gaithersburg, MD 20878
• Product Code: FRN
• Subsequent Product Code: FPA
• Subsequent Product Code: MRZ
• CFR Regulation Number: 880.5725 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-10-04
• Decision Date: 2020-11-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
27290109155214	K192860	000
27290109154910	K192860	000
27290109154927	K192860	000
27290109155139	K192860	000
17290109154050	K192860	000
27290109154071	K192860	000
17290109153046	K192860	000
27290109153067	K192860	000
27290109153081	K192860	000
27290109153098	K192860	000
27290109153104	K192860	000
27290109153128	K192860	000
27290109153135	K192860	000
27290109153159	K192860	000
27290109154903	K192860	000
27290109154880	K192860	000
27290109154866	K192860	000
27290109155870	K192860	000
27290109155887	K192860	000
27290109155283	K192860	000
27290109155306	K192860	000
27290109151650	K192860	000
17290109155095	K192860	000
27290109154705	K192860	000
27290109154590	K192860	000
27290109154804	K192860	000
27290109155115	K192860	000
27290109155146	K192860	000
17290109151288	K192860	000
27290109154491	K192860	000
27290109153173	K192860	000
27290109153180	K192860	000
27290109154200	K192860	000
27290109154224	K192860	000
27290109154255	K192860	000
27290109154279	K192860	000
27290109154286	K192860	000
27290109154316	K192860	000
27290109154347	K192860	000
27290109153142	K192860	000
27290109153050	K192860	000
27290109154330	K192860	000
27290109153166	K192860	000
27290109153111	K192860	000
27290109153074	K192860	000
27290109154194	K192860	000
27290109154125	K192860	000
17290109154111	K192860	000
27290109153197	K192860	000
27290109153203	K192860	000
27290109153883	K192860	000
27290109153890	K192860	000
27290109153913	K192860	000
27290109153944	K192860	000
27290109153951	K192860	000
27290109153968	K192860	000
27290109153975	K192860	000
27290109153999	K192860	000
27290109154026	K192860	000
27290109154033	K192860	000
27290109154088	K192860	000
27290109154262	K192860	000