The following data is part of a premarket notification filed by Siemens Medical Corp. with the FDA for Siemens Integrated Operating System (sios).
| Device ID | K994231 |
| 510k Number | K994231 |
| Device Name: | SIEMENS INTEGRATED OPERATING SYSTEM (SIOS) |
| Classification | Endoscopic Central Control Unit |
| Applicant | SIEMENS MEDICAL CORP. 186 WOOD AVE. SOUTH Iselin, NJ 08830 |
| Contact | Malgorzata Stanek |
| Correspondent | Malgorzata Stanek SIEMENS MEDICAL CORP. 186 WOOD AVE. SOUTH Iselin, NJ 08830 |
| Product Code | ODA |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-16 |
| Decision Date | 2000-08-10 |
| Summary: | summary |