FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AIR CONDUCTION HEARING AID
K Number: K944520
·
Decision Dec 27, 1994
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
1366
Applicant Total
69
Review Days
102
Basic Information
- Device Name
- AIR CONDUCTION HEARING AID
- K Number
- K944520
- 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
- UNITRON INDUSTRIES, INC.
- Date Received
- September 16, 1994
- Decision Date
- December 27, 1994
- 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 UNITRON INDUSTRIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K974339 | UNITRON MODEL SOUND F/XD PROGRAMMABLE | Dec 12, 1997 | Substantially Equivalent |
| K974340 | UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE | Dec 12, 1997 | Substantially Equivalent |
| K974338 | UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) | Dec 12, 1997 | Substantially Equivalent |
| K970692 | UNITRON MODEL SOUND F/X CIC | May 8, 1997 | Substantially Equivalent |
| K970519 | UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE) | Apr 24, 1997 | Substantially Equivalent |
| K964511 | UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4) | Nov 27, 1996 | Substantially Equivalent |
| K964504 | UNITRON MODEL ICON AOHPL +4 | Nov 27, 1996 | Substantially Equivalent |
| K964508 | UNITRON MODEL ICON AOHP +4 (ICON AOHP +4) | Nov 27, 1996 | Substantially Equivalent |
| K964502 | UNITRON MODEL SOUND F/XP +4 | Nov 27, 1996 | Substantially Equivalent |
| K964510 | UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4) | Nov 27, 1996 | Substantially Equivalent |