FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT
K Number: K112435
·
Decision Sep 22, 2011
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
96
Applicant Total
18
Review Days
29
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Basic Information
- Device Name
- RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT
- K Number
- K112435
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 874.1820
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rhythmlink International, LLC
- Date Received
- August 24, 2011
- Decision Date
- September 22, 2011
- Product Code
- ETN
- 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 |
|---|---|---|---|
| ETN | Stimulator, Nerve | FDA class 2 | Ear, Nose, Throat |
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| K130220 | MR CONDITIONAL PRESSON ELECTRODE | Jul 22, 2013 | Substantially Equivalent |
| K130287 | MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE | May 30, 2013 | Substantially Equivalent |
| K121347 | PRESSON ELECTRODE | Jul 12, 2012 | Substantially Equivalent |
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