FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ADJUSTRETTE - DAO, MODIFICATION
K Number: K911498
·
Decision Apr 19, 1991
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
39
Review Days
21
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Basic Information
- Device Name
- ADJUSTRETTE - DAO, MODIFICATION
- K Number
- K911498
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Qualitone
- Date Received
- March 29, 1991
- Decision Date
- April 19, 1991
- Product Code
- ESD
- 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 |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | FDA class 1 | Ear, Nose, Throat |
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Other Clearances by Qualitone
| K Number | Device Name | ||
|---|---|---|---|
| K961827 | IN-THE-EAR | Jul 3, 1996 | Substantially Equivalent |
| K955466 | DYNAMEQ-II OPTION | Feb 13, 1996 | Substantially Equivalent |
| K955359 | CYBER III OPTION UM, UC312, UC10, UCIC | Dec 19, 1995 | Substantially Equivalent |
| K953884 | PROPHET | Oct 27, 1995 | Substantially Equivalent |
| K935348 | ODYSSEY CLINICAL AUDIOMETER | Feb 9, 1994 | Substantially Equivalent |
| K935289 | PRO FIT-CYBER II OPTION | Dec 22, 1993 | Substantially Equivalent |
| K923006 | AS-90 | Sep 18, 1993 | Substantially Equivalent |
| K923007 | AT-2 | Feb 26, 1993 | Substantially Equivalent |
| K923986 | CYBERNETIC OPTION (CYBER I) | Sep 10, 1992 | Substantially Equivalent |
| K923013 | ACOUSTIC APPRAISE CD-3 | Aug 14, 1992 | Substantially Equivalent |