FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POST-AURICULAR HEARING AID MODEL ASP-103
K Number: K813344
·
Decision Dec 31, 1981
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
12
Review Days
36
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- POST-AURICULAR HEARING AID MODEL ASP-103
- K Number
- K813344
- 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
- November 25, 1981
- Decision Date
- December 31, 1981
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ESD), ordered by most recent decision date.
Lyric4 Hearing Aid
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
LYRIC2
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
LYRIC HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
INSOUND XT SERIES HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
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 |
| 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 |
| K801067 | TELESONIC, GENERIC & SOUNDEX C-102 | May 28, 1980 | Substantially Equivalent |
| K800105 | TELESONIC (HEARING AID) | Feb 11, 1980 | Substantially Equivalent |