Resound Corp.
Redwood City, CA, US
Resound Corp. appears in FDA device records in Redwood City, CA. FDA records list 41 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 41
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 41 510(k) clearances for Resound Corp. between 1989 and 1999. The busiest year on record is 1995, with 14. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 6 |
| 1990 | 1 |
| 1991 | 2 |
| 1992 | 1 |
| 1993 | 2 |
| 1994 | 3 |
| 1995 | 14 |
| 1996 | 7 |
| 1997 | 4 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K984547 | DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS | EWO | Substantially Equivalent | |
| K974257 | RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) | ESD | Substantially Equivalent | |
| K974081 | RESOUND STEALTH CIC | ESD | Substantially Equivalent | |
| K971605 | RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION | ESD | Substantially Equivalent | |
| K970215 | AUDALLION II HEARING SYSTEM | ESD | Substantially Equivalent | |
| K964557 | RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION | ESD | Substantially Equivalent | |
| K964115 | RESOUND CC4 PERSONAL HEARING SYSTEM | ESD | Substantially Equivalent | |
| K960684 | HEARING AID - AIR CONDUCTION | ESD | Substantially Equivalent | |
| K960680 | RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES, EDR-EV, & EDR-P1 | ESD | Substantially Equivalent | |
| K960052 | RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241 | ESD | Substantially Equivalent | |
| K960229 | RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM | ETW | Substantially Equivalent | |
| K955867 | RESOUND PERSONAL HEARING SYSTEM BT247 | ESD | Substantially Equivalent | |
| K955574 | RESOUND PERSONAL HEARING SYSTEM BTP W/DAI | ESD | Substantially Equivalent | |
| K953266 | RESOUND PERSONAL HEARING SYSTEM BT250 MZ W/REMOTE CONTROL OPTION | ESD | Substantially Equivalent | |
| K952228 | SONAR CIC COMPLETELY IN-THE-CANAL HEARING DEVICE | ESD | Substantially Equivalent | |
| K951068 | RESOUND ED4-M MINI-CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-M) | ESD | Substantially Equivalent | |
| K951067 | RESOUND ED4-C CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-C) | ESD | Substantially Equivalent | |
| K951379 | RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTION | ESD | Substantially Equivalent | |
| K951378 | RESOUND PERSONAL HEARING SYSTEM MODELS BTP2 & BTP2/S W/REMOTE CONTROL OPTION | ESD | Substantially Equivalent | |
| K951377 | RESOUND PERSONAL HEARING SYSTEM BTP/S-A W/REMOTE CONTROL OPTION | ESD | Substantially Equivalent | |
| K951376 | RESOUND PERSONAL HEARING SYSTEM BT2/S SERIES W/REMOTE CONTROL OPTION | ESD | Substantially Equivalent | |
| K951375 | RESOUND PERSONAL HEARING SYSTEM ED3/S-E | ESD | Substantially Equivalent | |
| K951374 | RESOUND PERSONAL HEARING SYSTEM BT2/S-E | ESD | Substantially Equivalent | |
| K945750 | RESOUND(R) RESOURCE(TM) | ESD | Substantially Equivalent | |
| K950319 | RESOUND(R) PERSONAL HEARING SYSTEM ED-3 ENCORE | ESD | Substantially Equivalent | |
| K934917 | RESOUND PERSONAL HEARING SYSTEMS MODIFICATION | ESD | Substantially Equivalent | |
| K944041 | PERSONAL HEARING SYSTEM | LRS | Substantially Equivalent | |
| K944043 | BTP-A HEARING SYSTEM | ESD | Substantially Equivalent | |
| K943788 | RESOUND PERSONAL HEARING SYSTEM | ESD | Substantially Equivalent | |
| K931372 | RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM | ESD | Substantially Equivalent | |
| K931942 | RESOUND PERSONAL HEARING SYSTEM BT-P W/PHS BT-P | ESD | Substantially Equivalent | |
| K922570 | RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1 | EPF | Substantially Equivalent | |
| K912669 | RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM | EWO | Substantially Equivalent | |
| K912665 | SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID | ESD | Substantially Equivalent | |
| K896463 | RESOUND CUSTOM IN-THE CANAL HEARING AID MODEL CA1 | ESD | Substantially Equivalent | |
| K894019 | RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE | KHL | Substantially Equivalent | |
| K893927 | RESOUND CUSTOM IN-THE CANAL HEARING AID PHS-3 | ESD | Substantially Equivalent | |
| K892935 | RESOUND IMPRESSION MATERIAL | ELW | Substantially Equivalent | |
| K891011 | RESOUND ITC HEARING ENHANCEMENT SYS HES2, W/REMOTE | ESD | Substantially Equivalent | |
| K884871 | RESOUND HES, DIGITALLY PROGR., ITE HEARING AID | ESD | Substantially Equivalent | |
| K884044 | AUDIOMETER DIGITAL HEARING SYSTEM | EWO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain