The following data is part of a premarket notification filed by Hill-rom, Inc. with the FDA for Hill-rom Patient Environmental Control System.
Device ID | K921528 |
510k Number | K921528 |
Device Name: | HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM |
Classification | System, Environmental Control, Powered |
Applicant | HILL-ROM, INC. HIGHWAY 46 Batesville, TN |
Contact | Ford Wilder |
Correspondent | Ford Wilder HILL-ROM, INC. HIGHWAY 46 Batesville, TN |
Product Code | IQA |
CFR Regulation Number | 890.3725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-02 |
Decision Date | 1992-04-20 |