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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 K232015
Device Name ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)
Applicant
Atmos Medizintechnik GmbH & Co. KG
Ludwig-Kegel-Str. 16
Lenzkirch,  DE 79853
Applicant Contact Reinhold Storch
Correspondent
Atmos Medizintechnik GmbH & Co. KG
Ludwig-Kegel-Str. 16
Lenzkirch,  DE 79853
Correspondent Contact Reinhold Storch
Regulation Number874.4760
Classification Product Code
EOB  
Date Received07/06/2023
Decision Date 08/03/2023
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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