ELECTRO INTERSTITIAL SCAN
FDA 510(k) clearance K102166 · decided 2010-12-10
Clearance details
- K-number
- K102166
- Device name
- ELECTRO INTERSTITIAL SCAN
- Applicant
- Ld Technology, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-08-02
- Decision date
- 2010-12-10
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- GZO
- Device class
- 2
- Regulation number
- 882.1540
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| QBioScan (K150804) | Medeia, Inc. | 2015-10-19 |
| SudoC (K152216) | Ld Technology, LLC | 2015-09-24 |
| SUDOSCAN (K141872) | Impeto Medical, Inc. | 2014-11-21 |
| SUDO PATH (K131568) | Ld Technology, LLC | 2013-06-28 |
| ZYTO HAND CRADLE (K111308) | Zyto Technologies, Inc. | 2011-08-30 |
| SUDOSCAN (K100233) | Impeto Medical | 2010-06-14 |
| MSAS-VANTAGE (K053004) | Biomeridian, Int. | 2006-01-13 |
| EPI-SCAN, MODEL P 100 (K032935) | Edx Epi-Scan, Inc. | 2003-11-20 |
| ASYRA (K023355) | Galloway Technologies, LLC | 2003-06-24 |
| ABR-2000 (K020360) | Meridian Co., Ltd. | 2002-08-29 |
| AKUPORT M1 (K020567) | Vibrant Health | 2002-05-02 |
| EAV KINDLING 2000S GSR DEVICE (K020564) | Virbrant Health | 2002-04-30 |
Recalls involving this device
No recalls on record reference this clearance.