The following data is part of a premarket notification filed by Quality In Flow Ltd. with the FDA for Warrior Blood And Fluid Warmer, Warrior Extreme Blood And Fluid Warmer, Warrior Lite Blood And Fluid Warmer.
| Device ID | K211800 |
| 510k Number | K211800 |
| Device Name: | Warrior Blood And Fluid Warmer, Warrior EXTREME Blood And Fluid Warmer, Warrior Lite Blood And Fluid Warmer |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | Quality In Flow Ltd. 11 Ha’avoda St. Rosh Ha’ayin, IL 4801761 |
| Contact | Omer Pechter |
| Correspondent | Omer Pechter Quality In Flow Ltd. 11 Ha’avoda St. Rosh Ha’ayin, IL 4801761 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-10 |
| Decision Date | 2022-12-08 |