CRONUS GUIDEWIRE, MODEL 001-001470-1— 510(k) K051373
Substantially EquivalentStereotaxis, Inc.
FDA 510(k) clearance K051373 for CRONUS GUIDEWIRE, MODEL 001-001470-1, Substantially Equivalent on 2005-12-09. Applicant: Stereotaxis, Inc.. Device class: 2.
Clearance details
- Applicant
- Stereotaxis, Inc.
- Product code
- Code NDQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1290
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Saint Louis, MO, US
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