The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Directlink Icp Module, Directlink Icp Extension Cable, Patient Monitor Interface Cables.
| Device ID | K152670 |
| 510k Number | K152670 |
| Device Name: | DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | Medos International SARL Chemin-Blanc 38 Le Locle, CH Ch-2400 |
| Contact | Elena Jugo |
| Correspondent | Elena Jugo Medos International SARL Chemin-Blanc 38 Le Locle, CH Ch-2400 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-17 |
| Decision Date | 2016-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780520801 | K152670 | 000 |
| 10381780520610 | K152670 | 000 |
| 10381780520719 | K152670 | 000 |
| 10381780520726 | K152670 | 000 |
| 10381780520733 | K152670 | 000 |
| 10381780520740 | K152670 | 000 |
| 10381780520757 | K152670 | 000 |
| 10381780520788 | K152670 | 000 |
| 10381780520795 | K152670 | 000 |
| 10381780515784 | K152670 | 000 |