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SPY-PHI System with SPY-PHI Fluorescence Assessment Software

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202244
510(k) Type
Traditional
Applicant
Novadaq Technologies ULC (now a part of Stryker)
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
11/5/2020
Days to Decision
87 days
Submission Type
Summary

SPY-PHI System with SPY-PHI Fluorescence Assessment Software

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202244
510(k) Type
Traditional
Applicant
Novadaq Technologies ULC (now a part of Stryker)
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
11/5/2020
Days to Decision
87 days
Submission Type
Summary