510(k) K994231
K994231 is an FDA 510(k) premarket notification submitted by Siemens Medical Corp. for the device "SIEMENS INTEGRATED OPERATING SYSTEM (SIOS)". The FDA issued a decision of Substantially Equivalent on August 10, 2000. The device falls under product code ODA (Endoscopic Central Control Unit), a Class II device regulated under 21 CFR 876.1500. Siemens Medical Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 2000
- Date Received
- December 16, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Central Control Unit
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.