FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BEHIND-THE-EAR HEARING AID, TELEX MODEL 361-PP
K Number: K931134
·
Decision Apr 14, 1993
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
1366
Applicant Total
50
Review Days
40
Basic Information
- Device Name
- BEHIND-THE-EAR HEARING AID, TELEX MODEL 361-PP
- K Number
- K931134
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TELEX COMMUNICATIONS, INC.
- Date Received
- March 5, 1993
- Decision Date
- April 14, 1993
- 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 TELEX COMMUNICATIONS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K984243 | TELEX TINNITUS-COMPANION | Jan 21, 1999 | Substantially Equivalent |
| K982683 | TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION | Oct 6, 1998 | Substantially Equivalent |
| K964639 | TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II | Jan 21, 1997 | Substantially Equivalent |
| K963915 | TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION | Nov 8, 1996 | Substantially Equivalent |
| K961143 | TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40 | May 7, 1996 | Substantially Equivalent |
| K954579 | TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION | Dec 8, 1995 | Substantially Equivalent |
| K943961 | THE MODEL ACAPPELLA IN THE EAR HEARING AID | May 15, 1995 | Substantially Equivalent |
| K935048 | ARTISAN PROGRAMMER & HEARING AID | Feb 9, 1994 | Substantially Equivalent |
| K935366 | BINAURAL HEARING AID | Jan 13, 1994 | Substantially Equivalent |
| K933579 | MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING AID | Aug 23, 1993 | Substantially Equivalent |