Last synced on 23 February 2024 at 11:04 pm

PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231970
510(k) Type
Traditional
Applicant
PENTAX of America, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/12/2024
Days to Decision
193 days
Submission Type
Summary

PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231970
510(k) Type
Traditional
Applicant
PENTAX of America, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/12/2024
Days to Decision
193 days
Submission Type
Summary