510(k) K090136
K090136 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "STERIS CMAX XLT SURGICAL TABLE". The FDA issued a decision of Substantially Equivalent on March 20, 2009. The device falls under product code FQO (Table, Operating-Room, Ac-Powered), a Class I device regulated under 21 CFR 878.4960. STERIS Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 2009
- Date Received
- January 21, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Operating-Room, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 878.4960
- Review Panel
- SU
- Submission Type