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WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K220399
510(k) Type
Traditional
Applicant
OTU Medical Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/16/2022
Days to Decision
125 days
Submission Type
Summary

WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K220399
510(k) Type
Traditional
Applicant
OTU Medical Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/16/2022
Days to Decision
125 days
Submission Type
Summary