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Brainlab Elements Guide XT, Guide 3.0

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213930
510(k) Type
Traditional
Applicant
Brainlab AG
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
4/19/2022
Days to Decision
124 days
Submission Type
Summary

Brainlab Elements Guide XT, Guide 3.0

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213930
510(k) Type
Traditional
Applicant
Brainlab AG
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
4/19/2022
Days to Decision
124 days
Submission Type
Summary