FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM
K Number: K013419
·
Decision Dec 20, 2001
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
8
Review Days
66
Basic Information
- Device Name
- NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM
- K Number
- K013419
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- NICOLET BIOMEDICAL
- Date Received
- October 15, 2001
- Decision Date
- December 20, 2001
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by NICOLET BIOMEDICAL
| K Number | Device Name | ||
|---|---|---|---|
| K020754 | NICOLET PIONEER TC8080 | Apr 21, 2003 | Substantially Equivalent |
| K013281 | VERSALAB APM | Apr 18, 2002 | Substantially Equivalent |
| K011135 | GSI AUDERA | Jul 26, 2001 | Substantially Equivalent |
| K010521 | NICOLET VERSALAB | Mar 9, 2001 | Substantially Equivalent |
| K002766 | NICOLET VASOGUARD | Nov 30, 2000 | Substantially Equivalent |
| K993939 | NICOLET EME LEGEND TC22 | Jun 29, 2000 | Substantially Equivalent |
| K982635 | CAREDOP II | Aug 7, 1998 | Substantially Equivalent |