FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SudoC
K Number: K152216
·
Decision Sep 24, 2015
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
25
Applicant Total
14
Review Days
48
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Basic Information
- Device Name
- SudoC
- K Number
- K152216
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.1540
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ld Technology, LLC
- Date Received
- August 7, 2015
- Decision Date
- September 24, 2015
- 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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Other Clearances by Ld Technology, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K200287 | BP-BT Kiosk | May 15, 2020 | Substantially Equivalent |
| K200141 | Oxi-W System | Apr 27, 2020 | Substantially Equivalent |
| K173696 | TBL-ABI System | Dec 19, 2017 | Substantially Equivalent |
| K160956 | LD-Oxi system | Jul 6, 2016 | Substantially Equivalent |
| K143152 | TM-ABI system | Jul 22, 2015 | Substantially Equivalent |
| K140412 | ANS1 SOFTWARE | May 22, 2014 | Substantially Equivalent |
| K131568 | SUDO PATH | Jun 28, 2013 | Substantially Equivalent |
| K130056 | PATIENT MONITOR | Apr 11, 2013 | Substantially Equivalent |
| K113264 | ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE) | Mar 2, 2012 | Substantially Equivalent |
| K103026 | ELECTRO SENSOR -BODY COMPOSITION | Mar 29, 2011 | Substantially Equivalent |