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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K183691
Device Name PENTAX Medical ENT Video Imaging System
Applicant
PENTAX of America, Inc.
3 Paragon Drive
Montvale,  NJ  07645 -1782
Applicant Contact William Goeller
Correspondent
PENTAX of America, Inc.
3 Paragon Drive
Montvale,  NJ  07645 -1782
Correspondent Contact William Goeller
Regulation Number874.4760
Classification Product Code
EOB  
Subsequent Product Code
PEA  
Date Received12/31/2018
Decision Date 06/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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