The following data is part of a premarket notification filed by Zyto Technologies, Inc with the FDA for Zyto Hand Cradle.
Device ID | K111308 |
510k Number | K111308 |
Device Name: | ZYTO HAND CRADLE |
Classification | Device, Galvanic Skin Response Measurement |
Applicant | ZYTO TECHNOLOGIES, INC 387 SOUTH 520 WEST SUITE 200 Lindon, UT 84042 |
Contact | Vaughn R Cook |
Correspondent | Vaughn R Cook ZYTO TECHNOLOGIES, INC 387 SOUTH 520 WEST SUITE 200 Lindon, UT 84042 |
Product Code | GZO |
CFR Regulation Number | 882.1540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-05-10 |
Decision Date | 2011-08-30 |
Summary: | summary |