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SPY Portable Handheld Imaging (SPY-PHI) System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190729
510(k) Type
Special
Applicant
Novadaq Technologies ULC. (now a part of Stryker)
Country
Canada
FDA Decision
Substantially Equivalent with Drug
Decision Date
4/19/2019
Days to Decision
29 days
Submission Type
Summary

SPY Portable Handheld Imaging (SPY-PHI) System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190729
510(k) Type
Special
Applicant
Novadaq Technologies ULC. (now a part of Stryker)
Country
Canada
FDA Decision
Substantially Equivalent with Drug
Decision Date
4/19/2019
Days to Decision
29 days
Submission Type
Summary