FDA 510(k) Application Details - K010998

Device Classification Name	Tonometer, Ac-Powered   More FDA Info for this Device
510(K) Number	K010998
Device Name	Tonometer, Ac-Powered
Applicant	LANGHAM OPHTHALMIC TECHNOLOGIES 9 CANDLELIGHT COURT TIMONIUM, MD 21093 US Other 510(k) Applications for this Company
Contact	MAURICE E LANGHAM 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	04/03/2001
Decision Date	06/27/2001
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review