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.
| 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 |