The following data is part of a premarket notification filed by Quality In Flow Ltd. with the FDA for Qif Blood And Fluid Warmer.
| Device ID | K171215 |
| 510k Number | K171215 |
| Device Name: | QiF Blood And Fluid Warmer |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | Quality In Flow Ltd. Kibutz Einat POB 29 Kibutz Einat, IL 4880500 |
| Contact | Neta Sherman |
| Correspondent | John Smith Hogan Lovells US LLP 555 Thirteenth St. NW Washington, DC 20004 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-25 |
| Decision Date | 2017-09-27 |
| Summary: | summary |