The following data is part of a premarket notification filed by Life Warmer, Inc. with the FDA for Quantum Blood And Iv Fluid Infusion Warmer.
| Device ID | K181775 |
| 510k Number | K181775 |
| Device Name: | Quantum Blood And IV Fluid Infusion Warmer |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | Life Warmer, Inc. 840 F. Avenue Suite 104 Plano, TX 75074 |
| Contact | John Pettini |
| Correspondent | John Pettini Life Warmer, Inc. 840 F. Avenue Suite 104 Plano, TX 75074 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-03 |
| Decision Date | 2019-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868058000492 | K181775 | 000 |
| 00868058000485 | K181775 | 000 |
| 00868058000447 | K181775 | 000 |
| 00868058000430 | K181775 | 000 |
| 00868058000423 | K181775 | 000 |
| 00868058000454 | K181775 | 000 |
| 00868058000461 | K181775 | 000 |