Bernafon-Maico, Inc.

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K982723MAICO MA42October 28, 1998
K981142MAICO MA53April 22, 1998
K974211OPUS 2 - FULL CONCHA SERIES - ITEDecember 15, 1997
K974069OPUS 2 - CANAL SERIES (ITC)December 15, 1997
K974152OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)December 15, 1997
K973948DUALINE 100 BTEOctober 28, 1997
K971158DUALINE 400 CICJune 13, 1997
K971080MAICO MA52June 6, 1997
K962275MAICO MA25 SERIES II WITH SPEECHSeptember 5, 1996