The following data is part of a premarket notification filed by Hill-rom, Inc. with the FDA for Stabilet.
Device ID | K942904 |
510k Number | K942904 |
Device Name: | STABILET |
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 | 1994-06-21 |
Decision Date | 1994-09-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() STABILET 74539342 1984990 Dead/Cancelled |
Hill-Rom Company, Inc. 1994-06-10 |
![]() STABILET 73501554 1391502 Dead/Cancelled |
BROEN ARMATUR A/S 1984-09-28 |