The following data is part of a premarket notification filed by Advanced Brain Monitoring Inc. with the FDA for X4 System.
Device ID | K130013 |
510k Number | K130013 |
Device Name: | X4 SYSTEM |
Classification | Reduced- Montage Standard Electroencephalograph |
Applicant | ADVANCED BRAIN MONITORING INC. W324 S3649 COUNTY ROAD E Dousman, WI 53118 |
Contact | Adrienne Lenz |
Correspondent | Adrienne Lenz ADVANCED BRAIN MONITORING INC. W324 S3649 COUNTY ROAD E Dousman, WI 53118 |
Product Code | OMC |
CFR Regulation Number | 882.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-01-02 |
Decision Date | 2013-01-31 |
Summary: | summary |