FDA 510(k) Application Details - K132549

Device Classification Name	Tonometer, Manual   More FDA Info for this Device
510(K) Number	K132549
Device Name	Tonometer, Manual
Applicant	ACCUTOME, INC. 3222 PHOENIXVILLE PIKE MALVERN, PA 19355 US Other 510(k) Applications for this Company
Contact	ADAM PICKHOLTZ Other 510(k) Applications for this Contact
Regulation Number	886.1930   More FDA Info for this Regulation Number
Classification Product Code	HKY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/14/2013
Decision Date	04/23/2014
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