FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238
K Number: K062549
·
Decision Oct 4, 2006
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
96
Applicant Total
58
Review Days
35
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Basic Information
- Device Name
- XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238
- K Number
- K062549
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1820
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Excel Tech. , Ltd.
- Date Received
- August 30, 2006
- Decision Date
- October 4, 2006
- Product Code
- ETN
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| ETN | Stimulator, Nerve | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Excel Tech. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K061269 | XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES | Aug 14, 2006 | Substantially Equivalent |
| K053386 | XLTEK EMU40 EEG HEADBOX, MODEL PK1072 | Apr 21, 2006 | Substantially Equivalent |
| K053058 | XLTEK NEUROPATH, MODEL PK1070 | Feb 7, 2006 | Substantially Equivalent |
| K052112 | XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 | Oct 28, 2005 | Substantially Equivalent |
| K052111 | XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382 | Aug 17, 2005 | Substantially Equivalent |
| K042223 | XLTEK CONNEX IP HEADBOX, MODEL 1054 | Sep 16, 2004 | Substantially Equivalent |
| K042150 | XLTEK TREX MODEL#10309 | Aug 27, 2004 | Substantially Equivalent |
| K040358 | XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 | Aug 6, 2004 | Substantially Equivalent |
| K040360 | EMU128S, MODEL EX-NW-128S | Mar 12, 2004 | Substantially Equivalent |
| K022037 | XLTEK SLEEP SYSTEM | Sep 10, 2002 | Substantially Equivalent |