FDA 510(k) Application Details - K180608

Device Classification Name	Pillow,Cervical(For Mild Sleep Apnea)   More FDA Info for this Device
510(K) Number	K180608
Device Name	Pillow,Cervical(For Mild Sleep Apnea)
Applicant	NightBalance BV Benoordenhoustseweg 46-13 Den Haag NL Other 510(k) Applications for this Company
Contact	Sophia Lam 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	03/07/2018
Decision Date	06/05/2018
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