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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K000401
Device Name VAPOTHERM, MODEL 2000I
Applicant
Vapotherm, Inc.
163 Conduit St.
Annapolis,  MD  21401
Applicant Contact WILLIAM NILAND
Correspondent
Vapotherm, Inc.
163 Conduit St.
Annapolis,  MD  21401
Correspondent Contact WILLIAM NILAND
Regulation Number868.5450
Classification Product Code
BTT  
Date Received02/07/2000
Decision Date 08/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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