K964873 is an FDA 510(k) clearance for the SILKAIR LOW AIRLOSS THERAPY. This device is classified as a Bed, Flotation Therapy, Powered (Class II - Special Controls, product code IOQ).
Submitted by Hill-Rom, Inc. (Charleston, US). The FDA issued a Cleared decision on July 3, 1997, 210 days after receiving the submission on December 5, 1996.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5170.
| 510(k) Number | K964873 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 1996 |
| Decision Date | July 03, 1997 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IOQ — Bed, Flotation Therapy, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5170 |