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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 K103042
Device Name ATMOS E 201 THORAX AND ATMOS S 201 THORAX
Applicant
ATMOS INC.
3717 HUCKLEBERRY ROAD
ALLENTOWN,  PA  18104
Applicant Contact MARCO SCHLEGEL
Correspondent
UNDERWRITERS LABORATORIES, INC.
12 LABORATORY DR.
RESEARCH TRIANGLE,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number878.4780
Classification Product Code
BTA  
Date Received10/14/2010
Decision Date 04/15/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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