FDA 510(k) Application Details - K161624

Device Classification Name	More FDA Info for this Device
510(K) Number	K161624
Device Name	MicrO2 OSA Device with Micro-Recorder
Applicant	MICRODENTAL, Inc. 5601 Arnold Rd. Dublin, CA 94568 US Other 510(k) Applications for this Company
Contact	David Kuhns 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	06/13/2016
Decision Date	11/07/2016
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