The following data is part of a premarket notification filed by Ld Technology Llc with the FDA for Sudo Path.
Device ID | K131568 |
510k Number | K131568 |
Device Name: | SUDO PATH |
Classification | Device, Galvanic Skin Response Measurement |
Applicant | LD TECHNOLOGY LLC 100 N. BISCAYNE BLVD, STE 500 Miami, FL 33132 |
Contact | Albert Maarek |
Correspondent | Albert Maarek LD TECHNOLOGY LLC 100 N. BISCAYNE BLVD, STE 500 Miami, FL 33132 |
Product Code | GZO |
CFR Regulation Number | 882.1540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-05-30 |
Decision Date | 2013-06-28 |
Summary: | summary |