FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERILE EMG ELECTRODES
K Number: K011818
·
Decision Sep 6, 2001
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
42
Applicant Total
10
Review Days
87
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STERILE EMG ELECTRODES
- K Number
- K011818
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 890.1385
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nicolet Biomedical, Inc.
- Date Received
- June 11, 2001
- Decision Date
- September 6, 2001
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IKT), ordered by most recent decision date.
Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)
FDA 510(k)
FDA Class 2
·Physical Medicine
Allergan Botox Needle Electrode
FDA 510(k)
FDA Class 2
·Physical Medicine
Myoject Luer Lock Needle Electrode
FDA 510(k)
FDA Class 2
·Physical Medicine
Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes
FDA 510(k)
FDA Class 2
·Physical Medicine
Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm
FDA 510(k)
FDA Class 2
·Physical Medicine
EMG RECORDING ELECTRODE ASSEMBLY
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Nicolet Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K021986 | BRAINET | Aug 23, 2002 | Substantially Equivalent |
| K021144 | SUBDURAL STRIP ELECTRODE | Jun 24, 2002 | Substantially Equivalent |
| K020218 | SNAP EEG MONITOR | Apr 22, 2002 | Substantially Equivalent |
| K020955 | NICOLET ELECTROCAUTERY DETECTOR | Apr 17, 2002 | Substantially Equivalent |
| K011823 | BIOREHAB SYSTEM | Sep 6, 2001 | Substantially Equivalent |
| K010019 | STERILE SUBDERMAL NEEDLE ELECTRODES | Mar 19, 2001 | Substantially Equivalent |
| K991054 | BRAVO MULTI-MODALITY SYSTEM | Nov 3, 1999 | Substantially Equivalent |
| K971331 | SATELLITE | Jun 25, 1997 | Substantially Equivalent |
| K950270 | NMI SOFTWARE | May 15, 1995 | Substantially Equivalent |