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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Air, Non-Manual, For Endoscope
510(k) Number K162152
Device Name Erbe’s CO2 Tubing/Cap Sets
Applicant
Erbe USA, Inc.
2225 Northwest Pkwy.
Marietta,  GA  30067
Applicant Contact John Tartal
Correspondent
Erbe USA, Inc.
2225 Northwest Pkwy.
Marietta,  GA  30067
Correspondent Contact John Tartal
Regulation Number876.1500
Classification Product Code
FEQ  
Date Received08/02/2016
Decision Date 08/31/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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