FDA 510(k) Application Details - K190353

Device Classification Name	More FDA Info for this Device
510(K) Number	K190353
Device Name	Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac
Applicant	Residential Home Sleep Services 4602 Beckley Road Battle Creek, MI 49015-7932 US Other 510(k) Applications for this Company
Contact	Chris Gillette Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/15/2019
Decision Date	04/10/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review