The following data is part of a premarket notification filed by Hill-rom, Inc. with the FDA for Critical Care Hospital Bed (icu/ccu).
Device ID | K915437 |
510k Number | K915437 |
Device Name: | CRITICAL CARE HOSPITAL BED (ICU/CCU) |
Classification | Bed, Ac-powered Adjustable Hospital |
Applicant | HILL-ROM, INC. HIGHWAY 46 Batesville, TN |
Contact | Ford Wilder |
Correspondent | Ford Wilder HILL-ROM, INC. HIGHWAY 46 Batesville, TN |
Product Code | FNL |
CFR Regulation Number | 880.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-26 |
Decision Date | 1992-06-11 |