FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OTICON DIGISOUND COMPACT
K Number: K973886
·
Decision Nov 4, 1997
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
9
Review Days
21
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
- OTICON DIGISOUND COMPACT
- K Number
- K973886
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Oticon, Inc.
- Date Received
- October 14, 1997
- Decision Date
- November 4, 1997
- 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 Oticon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973885 | OTICON DIGISOUND ITE | Nov 4, 1997 | Substantially Equivalent |
| K964683 | DIGIFOCUS ITE | Dec 12, 1996 | 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 |