The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Siemens Sc6000/sc6000p Bedside Monitoring System Enhanced With St Segment Analysis.
| Device ID | K974492 |
| 510k Number | K974492 |
| Device Name: | SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS |
| Classification | Monitor, St Segment With Alarm |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Contact | Jacqueline E M. Emery |
| Correspondent | Jacqueline E M. Emery SIEMENS MEDICAL SOLUTIONS USA, INC. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Product Code | MLD |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-28 |
| Decision Date | 1998-02-26 |
| Summary: | summary |