FDA 510(k) Application Details - K140190

Device Classification Name	Pillow,Cervical(For Mild Sleep Apnea)   More FDA Info for this Device
510(K) Number	K140190
Device Name	Pillow,Cervical(For Mild Sleep Apnea)
Applicant	ADVANCED BRAIN MONITORING, INC. W324 S3649 COUNTY RD E DOUSMAN, WI 53118 US Other 510(k) Applications for this Company
Contact	ADRIENNE LENZ Other 510(k) Applications for this Contact
Regulation Number	872.5570   More FDA Info for this Regulation Number
Classification Product Code	MYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/24/2014
Decision Date	05/29/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review