K964223 is an FDA 510(k) clearance for the CLINITRON RITE-HITE. This device is classified as a Bed, Air Fluidized (Class II - Special Controls, product code INX).
Submitted by Hill-Rom, Inc. (Charleston, US). The FDA issued a Cleared decision on May 28, 1997, 217 days after receiving the submission on October 23, 1996.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5160.
| 510(k) Number | K964223 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1996 |
| Decision Date | May 28, 1997 |
| Days to Decision | 217 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | INX — Bed, Air Fluidized |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5160 |