The following data is part of a premarket notification filed by Hill-rom, Inc. with the FDA for Affinity Bed Model 3600 Series.
Device ID | K915779 |
510k Number | K915779 |
Device Name: | AFFINITY BED MODEL 3600 SERIES |
Classification | Table, Obstetric (and Accessories) |
Applicant | HILL-ROM, INC. 1069 E. RT 46 Batesville, IN 47006 |
Contact | James G Carpenter |
Correspondent | James G Carpenter HILL-ROM, INC. 1069 E. RT 46 Batesville, IN 47006 |
Product Code | KNC |
CFR Regulation Number | 884.4900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-12-24 |
Decision Date | 1993-02-24 |