K970468 is an FDA 510(k) clearance for the KT AIR BED. This device is classified as a Mattress, Air Flotation, Alternating Pressure (Class II - Special Controls, product code FNM).
Submitted by Kinetic Concepts, Inc. (San Antonio, US). The FDA issued a Cleared decision on September 5, 1997, 210 days after receiving the submission on February 7, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5550.
| 510(k) Number | K970468 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 1997 |
| Decision Date | September 05, 1997 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FNM — Mattress, Air Flotation, Alternating Pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5550 |