FDA 510(k) Application Details - K180839

Device Classification Name	Tonometer, Manual   More FDA Info for this Device
510(K) Number	K180839
Device Name	Tonometer, Manual
Applicant	Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 Jena 07745 DE Other 510(k) Applications for this Company
Contact	Christian Muenster 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	03/30/2018
Decision Date	06/07/2018
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