The following data is part of a premarket notification filed by Hill-rom, Inc. with the FDA for The Genesis Bed From Hill-rom, Model 355 Series.
Device ID | K914309 |
510k Number | K914309 |
Device Name: | THE GENESIS BED FROM HILL-ROM, MODEL 355 SERIES |
Classification | Table, Obstetrical, Ac-powered (and Accessories) |
Applicant | HILL-ROM, INC. HIGHWAY 46 Batesville, TN |
Contact | Ford Wilder |
Correspondent | Ford Wilder HILL-ROM, INC. HIGHWAY 46 Batesville, TN |
Product Code | HDD |
CFR Regulation Number | 884.4900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-09-25 |
Decision Date | 1992-04-20 |