FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIGIFOCUS ITE
K Number: K964683
·
Decision Dec 12, 1996
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
9
Review Days
20
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Basic Information
- Device Name
- DIGIFOCUS ITE
- K Number
- K964683
- 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
- Oticon, Inc.
- Date Received
- November 22, 1996
- Decision Date
- December 12, 1996
- 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 Oticon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973885 | OTICON DIGISOUND ITE | Nov 4, 1997 | Substantially Equivalent |
| K973886 | OTICON DIGISOUND COMPACT | Nov 4, 1997 | Substantially Equivalent |
| K961059 | DIGIFOCUS COMPACT | May 7, 1996 | Substantially Equivalent |
| K960284 | OTICON /PRIMOFOCUS (PF) | Mar 7, 1996 | Substantially Equivalent |
| K954794 | OTICON | Nov 13, 1995 | Substantially Equivalent |
| K950381 | OTICON/LOGIC | Feb 27, 1995 | Substantially Equivalent |
| K946045 | OTICON | Jan 30, 1995 | Substantially Equivalent |
| K933307 | MULTIFOCUS COMPACT BTE HEARING AID | Aug 23, 1993 | Substantially Equivalent |