Electro Interstitial Scan
FDA 510(k) K102166 · Ld Technology, LLC
510(k) numberK102166
Submission
- Device name
- Electro Interstitial Scan
- Applicant
- Ld Technology, LLC
Miami, FL, US - Received
- August 2, 2010
- Decision date
- December 10, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K140412 | ANS1 SoftwareDXN · Special | 05/22/2014SE |
| K131568 | Sudo PathGZO · Special | 06/28/2013SE |
| K130056 | Patient MonitorMWI · Traditional | 04/11/2013SE |
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Questions and answers
When was Electro Interstitial Scan cleared by the FDA?
Electro Interstitial Scan (K102166) received a 510(k) decision of Substantially Equivalent on December 10, 2010, 130 days after the submission was received.
What is the product code of K102166?
The FDA product code is GZO – Device, Galvanic Skin Response Measurement, a Class II (moderate risk) device regulated under 21 CFR 882.1540.