The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Enflow Iv Fluid Warmer.
| Device ID | K112902 |
| 510k Number | K112902 |
| Device Name: | ENFLOW IV FLUID WARMER |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Contact | Stacie Geffner-atiya |
| Correspondent | Stacie Geffner-atiya VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-04 |
| Decision Date | 2012-03-14 |
| Summary: | summary |