K990715 is an FDA 510(k) clearance for the SHIMADZU CEILING TUBE SUPPORT CH-30GH. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by Shimadzu Corp. (Torrance, US). The FDA issued a Cleared decision on April 16, 1999, 43 days after receiving the submission on March 4, 1999.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K990715 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 1999 |
| Decision Date | April 16, 1999 |
| Days to Decision | 43 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | KPR — System, X-ray, Stationary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |