Last synced on 21 June 2024 at 11:04 pm

BLUE 400

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211346
510(k) Type
Traditional
Applicant
Carl Zeiss Meditec AG
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
7/22/2022
Days to Decision
445 days
Submission Type
Summary

BLUE 400

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211346
510(k) Type
Traditional
Applicant
Carl Zeiss Meditec AG
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
7/22/2022
Days to Decision
445 days
Submission Type
Summary