The following data is part of a premarket notification filed by Brainmaster Technologies, Inc. with the FDA for Qeeg-pro.
Device ID | K171414 |
510k Number | K171414 |
Device Name: | QEEG-Pro |
Classification | Normalizing Quantitative Electroencephalograph Software |
Applicant | Brainmaster Technologies, Inc. 195 Willis Street, Suite 3 Bedford, OH 44146 |
Contact | Tom Collura |
Correspondent | Maria Griffin mdi Consultants, Inc. 55 Northern Blvd, Suite 200 Great Neck, NY 11021 |
Product Code | OLU |
CFR Regulation Number | 882.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-05-15 |
Decision Date | 2018-07-01 |
Summary: | summary |