The following data is part of a premarket notification filed by Mri Interventions, Inc. with the FDA for Arcus Head Fixation Frame.
| Device ID | K191701 |
| 501k Number | K191701 |
| Device Name: | Arcus Head Fixation Frame |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | MRI Interventions, Inc. 5 Musick Irvine, CA 92618 |
| Contact | Pete Piferi |
| Correspondent | John J. Smith Hogan Lovells US LLP 555 Thirteenth St. NW Washington, DC 20004 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Neurology |
| 501k Review Panel | Neurology |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-25 |
| Decision Date | 2019-11-15 |