FDA 510(k) Application Details - K170527

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K170527
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	Phoenix Technology Group, Inc. dba Phoenix Clinical 6630 Owens Drive Pleasanton, CA 94588 US Other 510(k) Applications for this Company
Contact	Christopher A. Henderson Other 510(k) Applications for this Contact
Regulation Number	886.1120   More FDA Info for this Regulation Number
Classification Product Code	HKI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/22/2017
Decision Date	09/15/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review