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 |