FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OTICAON BTE MODEL E34P
K Number: K904673
·
Decision Nov 1, 1990
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
57
Review Days
20
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Basic Information
- Device Name
- OTICAON BTE MODEL E34P
- K Number
- K904673
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Oticon Corp.
- Date Received
- October 12, 1990
- Decision Date
- November 1, 1990
- 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 Oticon Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K963788 | PRIMOFOCUS COMPACT | Nov 27, 1996 | Substantially Equivalent |
| K932670 | OTICON MF | Aug 5, 1993 | Substantially Equivalent |
| K923490 | BTE HEARING AID PERSONIC 410 | Aug 6, 1992 | Substantially Equivalent |
| K923388 | BTE HEARING AID OTICON MODEL: MULTIFOCUS POWER | Aug 6, 1992 | Substantially Equivalent |
| K923491 | BTE HEARING AID PERSONIC 425 | Aug 6, 1992 | Substantially Equivalent |
| K905555 | A-ZILICONE | Jul 6, 1992 | Substantially Equivalent |
| K902559 | CUSTOM IN-THE-EAR HEARING AID OTICON MODEL: P | Jul 9, 1990 | Substantially Equivalent |
| K902351 | CUSTOM ITE HEARING AID MODELS C AND M | Jun 14, 1990 | Substantially Equivalent |
| K902352 | CUSTOM ITE HEARING AID MODEL: H | Jun 14, 1990 | Substantially Equivalent |
| K902353 | CUSTOM ITE HEARING AID MODELS F AND L | Jun 14, 1990 | Substantially Equivalent |