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Lux 35 Detector

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203159
510(k) Type
Special
Applicant
Carestream Health
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/2/2020
Days to Decision
40 days
Submission Type
Summary

Lux 35 Detector

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203159
510(k) Type
Special
Applicant
Carestream Health
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/2/2020
Days to Decision
40 days
Submission Type
Summary