FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTRO INTERSTITIAL SCAN
K Number: K102166
·
Decision Dec 10, 2010
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
25
Applicant Total
14
Review Days
130
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Basic Information
- Device Name
- ELECTRO INTERSTITIAL SCAN
- K Number
- K102166
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1540
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ld Technology, LLC
- Date Received
- August 2, 2010
- Decision Date
- December 10, 2010
- Product Code
- GZO
- 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 |
|---|---|---|---|
| GZO | Device, Galvanic Skin Response Measurement | FDA class 2 | Neurology |
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| K140412 | ANS1 SOFTWARE | May 22, 2014 | Substantially Equivalent |
| K131568 | SUDO PATH | Jun 28, 2013 | Substantially Equivalent |
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| K113264 | ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE) | Mar 2, 2012 | Substantially Equivalent |