The following data is part of a premarket notification filed by Brainmaster Technologies, Inc. with the FDA for Discovery 24.
| Device ID | K150498 |
| 510k Number | K150498 |
| Device Name: | Discovery 24 |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | BRAINMASTER TECHNOLOGIES, INC. 195 Willis Street, Suite 3 Bedford, OH 44146 |
| Contact | Mr. Tom Collura |
| Correspondent | Ms. Maria F. Griffin MDI CONSULTANTS, INC 55 NORTHERN BLVD. STE 200 Great Neck, NY 11021 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-26 |
| Decision Date | 2016-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852391007041 | K150498 | 000 |
| 00852391007010 | K150498 | 000 |