FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OLYMPIA FACEPLATE MODULE
K Number: K896304
·
Decision Jan 26, 1990
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
23
Applicant Total
2
Review Days
88
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Basic Information
- Device Name
- OLYMPIA FACEPLATE MODULE
- K Number
- K896304
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Olympia Instruments, Inc.
- Date Received
- October 30, 1989
- Decision Date
- January 26, 1990
- Product Code
- LRB
- 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 |
|---|---|---|---|
| LRB | Face Plate Hearing Aid | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRB), ordered by most recent decision date.
FACEPLATE ASSEMBLY
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INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS
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MODULE PROGRAM
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AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)
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ARTISAN PROGRAMMER & HEARING AID
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SILVER LD MODULE, ITE
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Other Clearances by Olympia Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K852244 | HEARING AID(ALL IN EAR) | Nov 7, 1985 | Substantially Equivalent |