Brainlab Elements Guide XT, Guide 3.0— 510(k) K213930
Substantially EquivalentBrainlab AG
FDA 510(k) clearance K213930 for Brainlab Elements Guide XT, Guide 3.0, Substantially Equivalent on 2022-04-19. Applicant: Brainlab AG. Device class: 2.
Clearance details
- Applicant
- Brainlab AG
- Product code
- Code QQC
- Device class
- Class 2
- Regulation
- 21 CFR 882.5855
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Munich, DE
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