Resound Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
41
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K984547DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDSMarch 19, 1999
K974257RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)December 12, 1997
K974081RESOUND STEALTH CICDecember 12, 1997
K971605RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTIONJuly 3, 1997
K970215AUDALLION II HEARING SYSTEMMarch 31, 1997
K964557RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTIONNovember 27, 1996
K964115RESOUND CC4 PERSONAL HEARING SYSTEMNovember 4, 1996
K960680RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES, EDR-EV, & EDR-P1April 10, 1996
K960684HEARING AID - AIR CONDUCTIONApril 10, 1996
K960052RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241March 12, 1996
K960229RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEMMarch 7, 1996
K955867RESOUND PERSONAL HEARING SYSTEM BT247February 2, 1996
K955574RESOUND PERSONAL HEARING SYSTEM BTP W/DAIDecember 22, 1995
K953266RESOUND PERSONAL HEARING SYSTEM BT250 MZ W/REMOTE CONTROL OPTIONJuly 26, 1995
K952228SONAR CIC COMPLETELY IN-THE-CANAL HEARING DEVICEJune 5, 1995
K951067RESOUND ED4-C CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-C)May 12, 1995
K951068RESOUND ED4-M MINI-CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-M)May 12, 1995
K951379RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTIONApril 27, 1995
K951378RESOUND PERSONAL HEARING SYSTEM MODELS BTP2 & BTP2/S W/REMOTE CONTROL OPTIONApril 27, 1995
K951375RESOUND PERSONAL HEARING SYSTEM ED3/S-EApril 14, 1995