FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DANTEC DISPOSABLE CONCENTRIC NEEDLE
K Number: K931966
·
Decision Mar 30, 1994
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
42
Applicant Total
25
Review Days
343
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Basic Information
- Device Name
- DANTEC DISPOSABLE CONCENTRIC NEEDLE
- K Number
- K931966
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1385
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dantec Medical, Inc.
- Date Received
- April 21, 1993
- Decision Date
- March 30, 1994
- 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)
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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
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EMG RECORDING ELECTRODE ASSEMBLY
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Other Clearances by Dantec Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960503 | DANTEC DUET | Sep 16, 1996 | Substantially Equivalent |
| K950314 | DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) | Mar 25, 1996 | Substantially Equivalent |
| K953999 | DANTEC DA CAPO | Nov 21, 1995 | Substantially Equivalent |
| K926363 | MULTI-DOP S | Jun 19, 1995 | Substantially Equivalent |
| K931801 | MULTI-DOP X | Jun 14, 1995 | Substantially Equivalent |
| K930458 | MULTI-DOP L | Feb 3, 1995 | Substantially Equivalent |
| K932059 | NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE | Oct 4, 1994 | Substantially Equivalent |
| K934580 | DANTEC 13R45 BAR ELECTRODE | Sep 26, 1994 | Substantially Equivalent |
| K931923 | DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE) | Nov 9, 1993 | Substantially Equivalent |
| K926516 | DANTEC MAGNETIC STIMULATOR MAGPRO | Aug 31, 1993 | Substantially Equivalent |