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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 K131946
Device Name ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS
Applicant
PENTAX MEDICAL COMPANY
3 Paragon Drive
MONTVALE,  NJ  07645 -1782
Applicant Contact KRISHNA GOVINDARAJAN
Correspondent
PENTAX MEDICAL COMPANY
3 Paragon Drive
MONTVALE,  NJ  07645 -1782
Correspondent Contact KRISHNA GOVINDARAJAN
Regulation Number874.4680
Classification Product Code
EOQ  
Subsequent Product Code
ITX  
Date Received06/27/2013
Decision Date 04/25/2014
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
Recalls CDRH Recalls
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