FDA 510(k) Application Details - K181571

Device Classification Name	More FDA Info for this Device
510(K) Number	K181571
Device Name	OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor
Applicant	Mark Abramson, D.D.S., Inc 35 Renato Court Redwood City, CA 94061 US Other 510(k) Applications for this Company
Contact	Mark Abramson 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	06/14/2018
Decision Date	04/19/2019
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