The following data is part of a premarket notification filed by Hill-rom, Inc. with the FDA for Stanilet Freestanding/cc Infant/2000c Infant Warmer (1250c/1500c/2000d).
| Device ID | K970074 |
| 510k Number | K970074 |
| Device Name: | STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D) |
| 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 | 1997-01-08 |
| Decision Date | 1997-04-03 |
| Summary: | summary |