The following data is part of a premarket notification filed by Fhc, Inc. with the FDA for Microtargeting Guideline 4000 5.0 System.
| Device ID | K183123 |
| 510k Number | K183123 |
| Device Name: | MicroTargeting Guideline 4000 5.0 System |
| Classification | Electrode, Depth |
| Applicant | FHC, Inc. 1201 Main Street Bowdoin, ME 04287 |
| Contact | Kelly Moeykens |
| Correspondent | Kelly Moeykens FHC, Inc. 1201 Main Street Bowdoin, ME 04287 |
| Product Code | GZL |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-13 |
| Decision Date | 2018-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00873263007358 | K183123 | 000 |
| 00873263006788 | K183123 | 000 |
| 00873263006771 | K183123 | 000 |
| 00873263006757 | K183123 | 000 |
| 00873263006740 | K183123 | 000 |
| 00873263007815 | K183123 | 000 |
| 00873263008058 | K183123 | 000 |
| 00873263008119 | K183123 | 000 |
| 00873263008188 | K183123 | 000 |
| 00873263008232 | K183123 | 000 |
| 00873263006795 | K183123 | 000 |
| 00873263006801 | K183123 | 000 |
| 00873263006818 | K183123 | 000 |
| 00873263007341 | K183123 | 000 |
| 00873263006924 | K183123 | 000 |
| 00873263006917 | K183123 | 000 |
| 00873263006900 | K183123 | 000 |
| 00873263006863 | K183123 | 000 |
| 00873263006856 | K183123 | 000 |
| 00873263006849 | K183123 | 000 |
| 00873263006832 | K183123 | 000 |
| 00873263006825 | K183123 | 000 |
| 00873263009185 | K183123 | 000 |