Last synced on 1 March 2024 at 11:05 pm

PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K232860
510(k) Type
Traditional
Applicant
PENTAX of America, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/18/2024
Days to Decision
125 days
Submission Type
Summary

PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K232860
510(k) Type
Traditional
Applicant
PENTAX of America, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/18/2024
Days to Decision
125 days
Submission Type
Summary