FDA 510(k) Application Details - K233516

Device Classification Name	Tonometer, Manual   More FDA Info for this Device
510(K) Number	K233516
Device Name	Tonometer, Manual
Applicant	Reichert, Inc. 3362 Walden Avenue, Suite 100 Depew, NY 14043 US Other 510(k) Applications for this Company
Contact	Elizabeth Schultz 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	11/01/2023
Decision Date	05/01/2024
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