The following data is part of a premarket notification filed by Alpine Biomed Aps with the FDA for Leadpoint Focus Workststion, Leadpoint Focus Notebook System.
| Device ID | K140680 |
| 510k Number | K140680 |
| Device Name: | LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM |
| Classification | Electrode, Depth |
| Applicant | ALPINE BIOMED APS TONSBAKKEN 16 - 18 Skovlunde, DK Dk-2740 |
| Contact | Seamus O'connor |
| Correspondent | Peter Jorgensen ALPINE BIOMED APS TONSBAKKEN 16 - 18 Skovlunde, DK Dk-2740 |
| Product Code | GZL |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-18 |
| Decision Date | 2014-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05704736019408 | K140680 | 000 |
| 05704736018746 | K140680 | 000 |
| 05704736018739 | K140680 | 000 |
| 05704736018722 | K140680 | 000 |
| 05704736018494 | K140680 | 000 |
| 05704736018012 | K140680 | 000 |
| 05704736009195 | K140680 | 000 |
| 00382830051101 | K140680 | 000 |
| 00382830050296 | K140680 | 000 |
| 00382830049399 | K140680 | 000 |
| 00382830049375 | K140680 | 000 |
| 00382830049290 | K140680 | 000 |
| 00382830049177 | K140680 | 000 |
| 05704736018753 | K140680 | 000 |
| 05704736018760 | K140680 | 000 |
| 05704736018777 | K140680 | 000 |
| 05704736018890 | K140680 | 000 |
| 05704736018883 | K140680 | 000 |
| 05704736018876 | K140680 | 000 |
| 05704736018869 | K140680 | 000 |
| 05704736018852 | K140680 | 000 |
| 05704736018845 | K140680 | 000 |
| 05704736018838 | K140680 | 000 |
| 05704736018821 | K140680 | 000 |
| 05704736018814 | K140680 | 000 |
| 05704736018807 | K140680 | 000 |
| 05704736018791 | K140680 | 000 |
| 05704736018784 | K140680 | 000 |
| 00382830049146 | K140680 | 000 |