FDA 510(k) Application Details - K234037

Device Classification Name	Tonometer, Manual   More FDA Info for this Device
510(K) Number	K234037
Device Name	Tonometer, Manual
Applicant	CATS Tonometer, LLC 1517 N. Wilmot Road, Suite 143 Tucson, AZ 85712 US Other 510(k) Applications for this Company
Contact	Sean McCafferty 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	12/21/2023
Decision Date	02/09/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review