The following data is part of a premarket notification filed by Hill-rom, Inc. with the FDA for Incuwarmer.
| Device ID | K971366 |
| 510k Number | K971366 |
| Device Name: | INCUWARMER |
| Classification | Warmer, Infant Radiant |
| Applicant | HILL-ROM, INC. 1069 STATE ROUTE 46 EAST Batesville, IN 47006 |
| Contact | James G Carpenter |
| Correspondent | James G Carpenter HILL-ROM, INC. 1069 STATE ROUTE 46 EAST Batesville, IN 47006 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-14 |
| Decision Date | 1998-01-05 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() INCUWARMER 75796647 2589051 Dead/Cancelled |
DRAEGER MEDICAL INFANT CARE, INC. 1999-09-10 |
![]() INCUWARMER 74620221 not registered Dead/Abandoned |
Hill-Rom, Inc. 1995-01-11 |