The following data is part of a premarket notification filed by Fhc, Inc. with the FDA for Microtargeting Xl Star Drive System.
| Device ID | K121950 |
| 510k Number | K121950 |
| Device Name: | MICROTARGETING XL STAR DRIVE SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | FHC, INC. 1201 MAIN ST Bowdoin, ME 04287 |
| Contact | Keri Seitz |
| Correspondent | Keri Seitz FHC, INC. 1201 MAIN ST Bowdoin, ME 04287 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-03 |
| Decision Date | 2012-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00873263002049 | K121950 | 000 |
| 00873263002063 | K121950 | 000 |