The following data is part of a premarket notification filed by Galloway Technologies, Llc with the FDA for Asyra.
Device ID | K023355 |
510k Number | K023355 |
Device Name: | ASYRA |
Classification | Device, Galvanic Skin Response Measurement |
Applicant | GALLOWAY TECHNOLOGIES, LLC 3736 PANARAMA DR. Saratoga Springs, UT 84043 |
Contact | Joe Galloway |
Correspondent | Joe Galloway GALLOWAY TECHNOLOGIES, LLC 3736 PANARAMA DR. Saratoga Springs, UT 84043 |
Product Code | GZO |
CFR Regulation Number | 882.1540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-07 |
Decision Date | 2003-06-24 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ASYRA 88527938 not registered Live/Pending |
Qest, LLC 2019-07-22 |
ASYRA 76424901 2875351 Dead/Cancelled |
Galloway, Mark 2002-06-26 |