FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇹 Austria
G.USBAMP
K Number: K060803
·
Decision May 2, 2006
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
52
Applicant Total
6
Review Days
39
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Basic Information
- Device Name
- G.USBAMP
- K Number
- K060803
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1835
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- G.Tec Medical Engineering GmbH
- Date Received
- March 24, 2006
- Decision Date
- May 2, 2006
- Product Code
- GWL
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GWL | Amplifier, Physiological Signal | FDA class 2 | Neurology |
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|---|---|---|---|
| K200088 | g.Estim FES | Oct 29, 2020 | Substantially Equivalent |
| K191432 | cortiQ PRO | Jan 24, 2020 | Substantially Equivalent |
| K173684 | g.Estim PRO | May 4, 2018 | Substantially Equivalent |
| K171669 | g.Nautilus PRO | Jul 5, 2017 | Substantially Equivalent |
| K123255 | g.HIamp | Dec 20, 2012 | Substantially Equivalent |