The following data is part of a premarket notification filed by Life Warmer, Inc. with the FDA for Quantum Blood And Fluid Warming System.
| Device ID | K192325 |
| 510k Number | K192325 |
| Device Name: | Quantum Blood And Fluid Warming System |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | Life Warmer, Inc. 4813 Keller Springs Rd Addison, TX 75001 |
| Contact | John Pettini |
| Correspondent | John Pettini Life Warmer, Inc. 4813 Keller Springs Rd Addison, TX 75001 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-27 |
| Decision Date | 2019-10-18 |