FDA 510(k) Application Details - K990257

Device Classification Name Tonometer, Ac-Powered

  More FDA Info for this Device
510(K) Number K990257
Device Name Tonometer, Ac-Powered
Applicant KEELER INSTRUMENTS, INC.
456 PKWY.
BROOMALL, PA 19008 US
Other 510(k) Applications for this Company
Contact EUGENE R VAN ARSDALE
Other 510(k) Applications for this Contact
Regulation Number 886.1930

  More FDA Info for this Regulation Number
Classification Product Code HKX
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 01/27/1999
Decision Date 03/25/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact