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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 K042245
Device Name VAPOTHERM MODEL#2000I, 200H
Applicant
Vapotherm, Inc.
6329 W. Waterview Ct.
Mccordsville,  IN  46055
Applicant Contact PAUL E DRYDEN
Correspondent
Vapotherm, Inc.
6329 W. Waterview Ct.
Mccordsville,  IN  46055
Correspondent Contact PAUL E DRYDEN
Regulation Number868.5450
Classification Product Code
BTT  
Date Received08/19/2004
Decision Date 08/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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