The following data is part of a premarket notification filed by Hill-rom Manufacturing, Inc. with the FDA for Isolette Infant Incubator, Model C2000e.
| Device ID | K031387 |
| 510k Number | K031387 |
| Device Name: | ISOLETTE INFANT INCUBATOR, MODEL C2000E |
| Classification | Incubator, Neonatal |
| Applicant | HILL-ROM MANUFACTURING, INC. 330 JACKSONVILLE RD. Hatboro, PA 19040 |
| Contact | Monica Ferrante |
| Correspondent | Monica Ferrante HILL-ROM MANUFACTURING, INC. 330 JACKSONVILLE RD. Hatboro, PA 19040 |
| Product Code | FMZ |
| CFR Regulation Number | 880.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-02 |
| Decision Date | 2003-08-01 |
| Summary: | summary |