K921528 is an FDA 510(k) clearance for the HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM. This device is classified as a System, Environmental Control, Powered (Class II - Special Controls, product code IQA).
Submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on April 20, 1992, 18 days after receiving the submission on April 2, 1992.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3725.
| 510(k) Number | K921528 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 1992 |
| Decision Date | April 20, 1992 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IQA — System, Environmental Control, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3725 |