Unitron Industries, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
69
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K974338UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)December 12, 1997
K974339UNITRON MODEL SOUND F/XD PROGRAMMABLEDecember 12, 1997
K974340UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTEDecember 12, 1997
K970692UNITRON MODEL SOUND F/X CICMay 8, 1997
K970519UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)April 24, 1997
K964504UNITRON MODEL ICON AOHPL +4November 27, 1996
K964503UNITRON MODEL SOUND F/X +4November 27, 1996
K964508UNITRON MODEL ICON AOHP +4 (ICON AOHP +4)November 27, 1996
K964502UNITRON MODEL SOUND F/XP +4November 27, 1996
K964510UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4)November 27, 1996
K964511UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4)November 27, 1996
K963122UNITRON MODEL ICON KRSeptember 6, 1996
K960155UNITRON MODEL SOUND F/XPMarch 7, 1996
K954516UNITRON MODEL SOUND F/X IIOctober 7, 1995
K953932UNITRON MODEL SOUND F/XDOctober 7, 1995
K953727UNITRON MODEL IKON AOHPDOctober 7, 1995
K954430UNITRON MODEL SOUND F/XOctober 6, 1995
K953646UNITRON MODEL IKON AOHPLAugust 28, 1995
K950759UNITRON MODEL ESTEEMMarch 31, 1995
K946323UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AIDJanuary 30, 1995