FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAREFUSION NICOLET EDX
K Number: K112052
·
Decision Mar 15, 2012
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
137
Applicant Total
5
Review Days
241
Basic Information
- Device Name
- CAREFUSION NICOLET EDX
- K Number
- K112052
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1870
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CAREFUSION 209, INC.
- Date Received
- July 18, 2011
- Decision Date
- March 15, 2012
- Product Code
- GWF
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | FDA class 2 | Neurology |
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Other Clearances by CAREFUSION 209, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K120979 | CAREFUSION NICOLET EDX | Apr 25, 2012 | Substantially Equivalent |
| K112034 | TECA ELITE DISPOSABLE CONCENTRIC NEEDLES | Aug 12, 2011 | Substantially Equivalent |
| K111131 | TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES | Jun 17, 2011 | Substantially Equivalent |
| K103140 | NICOLET WIRELESS EEG | Apr 8, 2011 | Substantially Equivalent |