FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMG RECORDING ELECTRODE ASSEMBLY
K Number: K120342
·
Decision Jun 22, 2012
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
42
Applicant Total
18
Review Days
140
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Basic Information
- Device Name
- EMG RECORDING ELECTRODE ASSEMBLY
- K Number
- K120342
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1385
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rhythmlink International, LLC
- Date Received
- February 3, 2012
- Decision Date
- June 22, 2012
- Product Code
- IKT
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| IKT | Electrode, Needle, Diagnostic Electromyograph | FDA class 2 | Physical Medicine |
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|---|---|---|---|
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| K130287 | MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE | May 30, 2013 | Substantially Equivalent |
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