The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Siemens Infinity Sc 6002xl Enhanced With St Segment Analysis.
| Device ID | K002105 |
| 510k Number | K002105 |
| Device Name: | SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS |
| Classification | Monitor, St Segment With Alarm |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Contact | Penelope H Greco |
| Correspondent | Penelope H Greco SIEMENS MEDICAL SOLUTIONS USA, INC. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Product Code | MLD |
| Subsequent Product Code | MHX |
| Subsequent Product Code | MSX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-12 |
| Decision Date | 2000-12-05 |