FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT
K Number: K952263
·
Decision Jun 5, 1995
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
42
Review Days
21
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Basic Information
- Device Name
- PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT
- K Number
- K952263
- 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
- Siemens Hearing Instruments, Inc.
- Date Received
- May 15, 1995
- Decision Date
- June 5, 1995
- 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 Siemens Hearing Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K071462 | UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) | Jun 5, 2007 | Substantially Equivalent |
| K011364 | CUSTOM TCI (TINNITUS CONTROL INSTRUMENT) | Jun 7, 2001 | Substantially Equivalent |
| K011366 | CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | Jun 1, 2001 | Substantially Equivalent |
| K003559 | TCI (TINNITUS CONTROL INSTRUMENT) | Apr 26, 2001 | Substantially Equivalent |
| K003558 | TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | Apr 24, 2001 | Substantially Equivalent |
| K972998 | PRISMA | Sep 5, 1997 | Substantially Equivalent |
| K962170 | SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP | Jul 25, 1996 | Substantially Equivalent |
| K952940 | PERSONAL PROGRAMMER 2000 | Jul 26, 1995 | Substantially Equivalent |
| K951828 | FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT | Jun 30, 1995 | Substantially Equivalent |
| K951896 | INTELIVENIENCE PROGRAMMABLE FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT | May 30, 1995 | Substantially Equivalent |