ASYRA— 510(k) K023355
Substantially EquivalentGalloway Technologies, LLC
FDA 510(k) clearance K023355 for ASYRA, Substantially Equivalent on 2003-06-24. Applicant: Galloway Technologies, LLC. Device class: 2.
Clearance details
- Applicant
- Galloway Technologies, LLC
- Product code
- Code GZO
- Device class
- Class 2
- Regulation
- 21 CFR 882.1540
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Saratoga Springs, UT, US
Recent devices under product code GZO
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