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 |