SudoC
510(k) K152216
SudoC is a Class II device made by Ld Technology, LLC, cleared under FDA 510(k) K152216 on 24 Sep 2015, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152216 | Date24 Sep 2015 | StatusActive |
Official records
- FDA 510(k) database K152216
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GZO
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1540
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K152216
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| SweatC A001 | A001 | B322A0011 | — | On the market |
Similar devices
Other devices filed under FDA product code GZO (Device, Galvanic Skin Response Measurement).
- Cadwell Guardian 190312-200 by Cadwell Industries, Inc.
- E-READER by Natural Herbal Products, Inc.
- EPI-SCAN, MODEL P 100 by Edx Epi-Scan, Inc.
- QBioScan by MEDEIA INC
- BIOFIND by Bioscan, Inc.
- GALVANIC SKIN RESPONSE DEVICE by Global Ent.
- DERMATRON SKIN RESISTANCE METER by Raymar Electronics
- UNIVERSAL EXAMINATION TABLE by Engineering Dynamics Corp.
- MERIDIAN-II AND MERDIAN-PLUS by Meridian AG
- Cadwell Guardian 199332-000 by Cadwell Industries, Inc.