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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 -9501
Applicant Contact PAUL E DRYDEN
Correspondent
VAPOTHERM, INC.
6329 W.WATERVIEW CT.
MCCORDSVILLE,  IN  46055 -9501
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
Recalls CDRH Recalls
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