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Image1 S CCU, Image1 S 4U Camera Head

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201135
510(k) Type
Traditional
Applicant
Karl Storz Endoscopy-America, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/1/2020
Days to Decision
126 days
Submission Type
Summary

Image1 S CCU, Image1 S 4U Camera Head

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K201135
510(k) Type
Traditional
Applicant
Karl Storz Endoscopy-America, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/1/2020
Days to Decision
126 days
Submission Type
Summary