FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INTEGRA, CUSTOM IN-THE-EAR HEARING AID
K Number: K864180
·
Decision Nov 5, 1986
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
16
Review Days
9
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Basic Information
- Device Name
- INTEGRA, CUSTOM IN-THE-EAR HEARING AID
- K Number
- K864180
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Bernafon, Inc.
- Date Received
- October 27, 1986
- Decision Date
- November 5, 1986
- 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 Bernafon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880349 | MODEL 759 CUSTOM IN-THE-EAR HEARING AID | Mar 7, 1988 | Substantially Equivalent |
| K874589 | BERNAFON COLIBRI, C-2H HEARING AIDS | Dec 4, 1987 | Substantially Equivalent |
| K864823 | BEHIND THE EAR HEARING AIDS, BERNAFON COLIBRI, C1 | Jan 6, 1987 | Substantially Equivalent |
| K860759 | CHARISMA HEARING AID | Apr 11, 1986 | Substantially Equivalent |
| K855240 | BEHIND THE EAR HEARING AIDS MODEL | Mar 12, 1986 | Substantially Equivalent |
| K851547 | BEHIND THE EAR HEARING AID MODEL BERNAFON T-82 | May 29, 1985 | Substantially Equivalent |
| K844985 | IN THE EAR MODEL X-ITE 84 | Jan 23, 1985 | Substantially Equivalent |
| K844621 | BEHIND THE EAR HEARING AID BERNAFON T-88P | Jan 7, 1985 | Substantially Equivalent |
| K844425 | BEHIND THE EAR HEARING AIDS BERNAFON X-13 | Jan 4, 1985 | Substantially Equivalent |
| K842546 | CUSTOM CANAL HEARING AID X-CITE 84 | Sep 5, 1984 | Substantially Equivalent |