FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC
K Number: K891247
·
Decision Mar 29, 1989
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
42
Review Days
21
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Basic Information
- Device Name
- BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC
- K Number
- K891247
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3500
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Siemens Hearing Instruments, Inc.
- Date Received
- March 8, 1989
- Decision Date
- March 29, 1989
- Product Code
- ESF
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| ESF | Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ESF), ordered by most recent decision date.
View allOther 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 |
| K952263 | PROGRAMMABLE TWO MEMORY, SINGLE BAND BEHIND THE EAR HEARING INSTRUMENT | Jun 5, 1995 | Substantially Equivalent |