Tomey Corporation USA

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K971953CONFOSCANAugust 14, 1997
K971685IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEMJune 24, 1997
K961805TOMEY DTL ELECTRODEMay 9, 1997
K932571TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4August 31, 1995
K945959VIDEO VISION ANALYZER (VIVA), VRB 100March 1, 1995
K944910TOMEY EM-1000 SPECULAR MICROSCOPENovember 22, 1994
K924760TOMEY PROTON TONOMETERApril 5, 1993
K921815TOMEY PE-300 PORTABLE ERGJuly 15, 1992
K912112PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480June 17, 1991