K943385 is an FDA 510(k) clearance for the CLINITRON ELEXIS. This device is classified as a Bed, Air Fluidized (Class II - Special Controls, product code INX).
Submitted by Ssi Medical Services, Inc. (Charleston, US). The FDA issued a Cleared decision on February 27, 1995, 229 days after receiving the submission on July 13, 1994.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5160.
| 510(k) Number | K943385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1994 |
| Decision Date | February 27, 1995 |
| Days to Decision | 229 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | INX — Bed, Air Fluidized |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5160 |