The following data is part of a premarket notification filed by Memory Md Inc with the FDA for Neurocap (model Dec22).
Device ID | K202913 |
510k Number | K202913 |
Device Name: | NeuroCap (Model DEC22) |
Classification | Electrode, Cutaneous |
Applicant | Memory MD Inc 125 Wilbur Place, Suite 170 Bohemia, NY 11171 6 |
Contact | Boris Goldstein |
Correspondent | Mike Corcoran Mtak LLC 8241 Enclave Cove Woodbury, MN 55125 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-29 |
Decision Date | 2021-03-05 |