The following data is part of a premarket notification filed by Creche Innovations with the FDA for Penguin In-line Warmer.
| Device ID | K150484 |
| 510k Number | K150484 |
| Device Name: | Penguin In-Line Warmer |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | Creche Innovations 17745 Metcalf One Penguin Plaza Stilwell, KS 66085 |
| Contact | Rebecca P Pine |
| Correspondent | Rebecca K Pine Creche Innovations 17745 Metcalf One Penguin Plaza Stilwell, KS 66085 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-24 |
| Decision Date | 2015-07-09 |
| Summary: | summary |