K913436 is an FDA 510(k) clearance for the PXI PNEUMATIC COMPRESSION PADDLE. This device is classified as a System, X-ray, Photofluorographic (Class II - Special Controls, product code IZG).
Submitted by Brotherston/Pxi (Pennsauken, US). The FDA issued a Cleared decision on November 5, 1992, 462 days after receiving the submission on August 1, 1991.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1730.
| 510(k) Number | K913436 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 1991 |
| Decision Date | November 05, 1992 |
| Days to Decision | 462 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IZG — System, X-ray, Photofluorographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1730 |