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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K121747
Device Name FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS
Applicant
Intersurgical Incorporated
417 Electronics Pkwy.
Liverpool,  NY  13088
Applicant Contact MICHAEL ZALEWSKI
Correspondent
Intersurgical Incorporated
417 Electronics Pkwy.
Liverpool,  NY  13088
Correspondent Contact MICHAEL ZALEWSKI
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/14/2012
Decision Date 03/14/2013
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
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