The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Multlink Cable And Leadwire System.
| Device ID | K082851 |
| 510k Number | K082851 |
| Device Name: | MULTLINK CABLE AND LEADWIRE SYSTEM |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 9900 INNOVATION DR. RP-2122 Wauwatosa, WI 53226 |
| Contact | Matthias Buerger |
| Correspondent | Matthias Buerger GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 9900 INNOVATION DR. RP-2122 Wauwatosa, WI 53226 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-29 |
| Decision Date | 2008-11-19 |
| Summary: | summary |