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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 K233707
Device Name HFT150
Applicant
Invent Medical Corporation
2788 Loker Ave. W.
Carlsbad,  CA  92010
Applicant Contact David Gramse
Correspondent
Invent Medical Corporation
2788 Loker Ave. W.
Carlsbad,  CA  92010
Correspondent Contact David Gramse
Regulation Number868.5450
Classification Product Code
BTT  
Date Received11/20/2023
Decision Date 06/14/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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