K090136 is an FDA 510(k) clearance for the STERIS CMAX XLT SURGICAL TABLE. This device is classified as a Table, Operating-room, Ac-powered (Class I - General Controls, product code FQO).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on March 20, 2009, 58 days after receiving the submission on January 21, 2009.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4960.
| 510(k) Number | K090136 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2009 |
| Decision Date | March 20, 2009 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FQO — Table, Operating-room, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4960 |