FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS
K Number: K984547
·
Decision Mar 19, 1999
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
234
Applicant Total
41
Review Days
87
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Basic Information
- Device Name
- DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS
- K Number
- K984547
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1050
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Resound Corp.
- Date Received
- December 22, 1998
- Decision Date
- March 19, 1999
- Product Code
- EWO
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EWO | Audiometer | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Resound Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K974081 | RESOUND STEALTH CIC | Dec 12, 1997 | Substantially Equivalent |
| K974257 | RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) | Dec 12, 1997 | Substantially Equivalent |
| K971605 | RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION | Jul 3, 1997 | Substantially Equivalent |
| K970215 | AUDALLION II HEARING SYSTEM | Mar 31, 1997 | Substantially Equivalent |
| K964557 | RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION | Nov 27, 1996 | Substantially Equivalent |
| K964115 | RESOUND CC4 PERSONAL HEARING SYSTEM | Nov 4, 1996 | Substantially Equivalent |
| K960684 | HEARING AID - AIR CONDUCTION | Apr 10, 1996 | Substantially Equivalent |
| K960680 | RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES, EDR-EV, & EDR-P1 | Apr 10, 1996 | Substantially Equivalent |
| K960052 | RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241 | Mar 12, 1996 | Substantially Equivalent |
| K960229 | RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM | Mar 7, 1996 | Substantially Equivalent |