FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TELESONIC, GENERIC & SOUNDEX C-102
K Number: K801067
·
Decision May 28, 1980
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
12
Review Days
22
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Basic Information
- Device Name
- TELESONIC, GENERIC & SOUNDEX C-102
- K Number
- K801067
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Telesonic, Inc.
- Date Received
- May 6, 1980
- Decision Date
- May 28, 1980
- 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 Telesonic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K872606 | TELESONIC BODY STIMULATOR | Dec 22, 1987 | Substantially Equivalent |
| K813330 | POST-AURICULAR HEARING AID MODEL S-101 | Jan 19, 1982 | Substantially Equivalent |
| K813329 | POST-AURICULAR HEARING AID MODEL P-101 | Jan 19, 1982 | Substantially Equivalent |
| K813344 | POST-AURICULAR HEARING AID MODEL ASP-103 | Dec 31, 1981 | Substantially Equivalent |
| K813316 | CUSTOM-IN-THE-EAR HEARING AID | Dec 31, 1981 | Substantially Equivalent |
| K811031 | TELESONIC & ARCON | Jul 1, 1981 | Substantially Equivalent |
| K802596 | TELESONIC, ARCON & SOUNDEX ASP 102 | Nov 12, 1980 | Substantially Equivalent |
| K802597 | TELESONIC ARCON & SOUNDEX ASP 101 | Nov 12, 1980 | Substantially Equivalent |
| K801066 | TELESONIC, SOUNDEX & GENERIC V-101 | May 28, 1980 | Substantially Equivalent |
| K800105 | TELESONIC (HEARING AID) | Feb 11, 1980 | Substantially Equivalent |