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 |