The following data is part of a premarket notification filed by Advanced Brain Monitoring, Inc. with the FDA for X4.
| Device ID | K120447 |
| 510k Number | K120447 |
| Device Name: | X4 |
| Classification | Reduced- Montage Standard Electroencephalograph |
| Applicant | ADVANCED BRAIN MONITORING, INC. W324 S3649 COUNTY RD E Dousman, WI 53118 |
| Contact | Adrienne Lenz |
| Correspondent | Adrienne Lenz ADVANCED BRAIN MONITORING, INC. W324 S3649 COUNTY RD E Dousman, WI 53118 |
| Product Code | OMC |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-14 |
| Decision Date | 2012-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851113007239 | K120447 | 000 |
| 10851113007229 | K120447 | 000 |
| 20851113007219 | K120447 | 000 |
| 00851113007161 | K120447 | 000 |