NOVALIS (SHAPED BEAM SURGERY SYSTEM)— 510(k) K002509
Substantially EquivalentBrainlab AG
FDA 510(k) clearance K002509 for NOVALIS (SHAPED BEAM SURGERY SYSTEM), Substantially Equivalent on 2000-11-03. Applicant: Brainlab AG. Device class: 2.
Clearance details
- Applicant
- Brainlab AG
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Heimstetten, DE
Recent devices under product code MUJ
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