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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K231970
Device Name 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
Applicant
Pentax of America, Inc.
3 Paragon Dr.,
Montvale,  NJ  07645
Applicant Contact William Goeller
Correspondent
Pentax of America, Inc.
3 Paragon Dr.,
Montvale,  NJ  07645
Correspondent Contact Gurvinder Singh Nanda
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received07/03/2023
Decision Date 01/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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