The following data is part of a premarket notification filed by Hill-rom, Inc. with the FDA for Totalcare.
Device ID | K962942 |
510k Number | K962942 |
Device Name: | TOTALCARE |
Classification | Bed, Ac-powered Adjustable Hospital |
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 | FNL |
CFR Regulation Number | 880.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-29 |
Decision Date | 1997-02-03 |
Summary: | summary |