FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT
K Number: K083488
·
Decision Feb 19, 2009
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
76
Applicant Total
4
Review Days
86
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Basic Information
- Device Name
- JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT
- K Number
- K083488
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 874.3400
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Audifon-USA, Inc.
- Date Received
- November 25, 2008
- Decision Date
- February 19, 2009
- Product Code
- KLW
- 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 |
|---|---|---|---|
| KLW | Masker, Tinnitus | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Audifon-USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K130514 | AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT | Nov 21, 2013 | Substantially Equivalent |
| K130417 | AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S | Sep 12, 2013 | Substantially Equivalent |
| K121793 | AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON | Nov 1, 2012 | Substantially Equivalent |