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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889483577530 | K082851 | 000 |
| 10889483577561 | K082851 | 000 |
| 10889483578636 | K082851 | 000 |
| 10889483581216 | K082851 | 000 |
| 10889483581223 | K082851 | 000 |
| 10889483581247 | K082851 | 000 |
| 10889483581254 | K082851 | 000 |
| 10889483582145 | K082851 | 000 |
| 10889483582152 | K082851 | 000 |
| 10889483577554 | K082851 | 000 |
| 10889483576441 | K082851 | 000 |
| 10889483577547 | K082851 | 000 |
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| 10889483576069 | K082851 | 000 |
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| 10889483578650 | K082851 | 000 |
| 10889483582114 | K082851 | 000 |
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| 10889483582138 | K082851 | 000 |
| 10889483590850 | K082851 | 000 |
| 10889483590867 | K082851 | 000 |
| 10889483590874 | K082851 | 000 |
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| 10889483577523 | K082851 | 000 |
| 10889483577516 | K082851 | 000 |
| 10889483590904 | K082851 | 000 |
| 10889483590935 | K082851 | 000 |
| 10889483590966 | K082851 | 000 |
| 10889483619971 | K082851 | 000 |
| 10889483619988 | K082851 | 000 |
| 10889483619995 | K082851 | 000 |
| 10889483620045 | K082851 | 000 |
| 10889483575635 | K082851 | 000 |
| 10889483590959 | K082851 | 000 |