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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K241799
Device Name ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C
Applicant
Atmos Medizintechnik GmbH & Co. KG
Ludwig-Kegel-Str. 16
Lenzkirch,  DE 79853
Applicant Contact Abdulaziz Abdunasimov
Correspondent
Atmos Medizintechnik GmbH & Co. KG
Ludwig-Kegel-Str. 16
Lenzkirch,  DE 79853
Correspondent Contact Abdulaziz Abdunasimov
Regulation Number878.4780
Classification Product Code
BTA  
Date Received06/21/2024
Decision Date 03/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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