FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMPLAID A315 AND A319
K Number: K983915
·
Decision Jan 29, 1999
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
234
Applicant Total
8
Review Days
86
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Basic Information
- Device Name
- AMPLAID A315 AND A319
- K Number
- K983915
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1050
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Amplifon S.P.A.
- Date Received
- November 4, 1998
- Decision Date
- January 29, 1999
- Product Code
- EWO
- 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 |
|---|---|---|---|
| EWO | Audiometer | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Amplifon S.P.A.
| K Number | Device Name | ||
|---|---|---|---|
| K992370 | AMPLAID A724 AND A728 | Sep 20, 1999 | Substantially Equivalent |
| K983712 | AMPLAID A311 SERIES | Jan 12, 1999 | Substantially Equivalent |
| K971740 | AMPLAID MK12 | Mar 16, 1998 | Substantially Equivalent |
| K974235 | AMPLAID AM50 | Feb 10, 1998 | Substantially Equivalent |
| K972959 | AMPLAID MK22 | Feb 6, 1998 | Substantially Equivalent |
| K972862 | AMPLAID 171S | Oct 31, 1997 | Substantially Equivalent |
| K971747 | AMPLAID 460 | Aug 5, 1997 | Substantially Equivalent |