K950756 is an FDA 510(k) clearance for the PULMONEX DYNAMIC AIR THERAPY UNIT. This device is classified as a Bed, Patient Rotation, Powered (Class II - Special Controls, product code IKZ).
Submitted by Hill-Rom, Inc. (Charleston, US). The FDA issued a Cleared decision on May 30, 1995, 102 days after receiving the submission on February 17, 1995.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5225.
| 510(k) Number | K950756 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 1995 |
| Decision Date | May 30, 1995 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IKZ — Bed, Patient Rotation, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5225 |