EXACTRAC ROBOTICS NOVALIS ROBOTICS— 510(k) K120520
Substantially EquivalentBrainlab AG
FDA 510(k) clearance K120520 for EXACTRAC ROBOTICS NOVALIS ROBOTICS, Substantially Equivalent on 2012-06-29. Applicant: Brainlab AG. Device class: 2.
Clearance details
- Applicant
- Brainlab AG
- Product code
- Code JAI
- Device class
- Class 2
- Regulation
- 21 CFR 892.5770
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Feldkirchen, DE
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