FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEARING AID-MODEL 2010
K Number: K780667
·
Decision May 3, 1978
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
14
Review Days
12
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Basic Information
- Device Name
- HEARING AID-MODEL 2010
- K Number
- K780667
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Radioear Corp.
- Date Received
- April 21, 1978
- Decision Date
- May 3, 1978
- 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 Radioear Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K841934 | RADIOEAR M430 PP | Sep 7, 1984 | Substantially Equivalent |
| K841933 | RADIOEAR M420H | Aug 10, 1984 | Substantially Equivalent |
| K841474 | HEARING AID MODEL P500 | Jun 22, 1984 | Substantially Equivalent |
| K841475 | HEARING AID MODEL M400 | Jun 22, 1984 | Substantially Equivalent |
| K841473 | HEARING AID MODEL 440PPC | Jun 22, 1984 | Substantially Equivalent |
| K834523 | MODEL M410D HEARING AID | Feb 10, 1984 | Substantially Equivalent |
| K811522 | RE-HP SERIES HEARING AIDS | Jun 26, 1981 | Substantially Equivalent |
| K800945 | RADIOEAR MODEL REI HEARING AID | May 8, 1980 | Substantially Equivalent |
| K800567 | RADIOEAR MODEL RM-L & RM-C HEARING AID | Apr 29, 1980 | Substantially Equivalent |
| K800332 | RADIOEAR MODEL 2080 (HEARING AID) | Mar 5, 1980 | Substantially Equivalent |