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 |