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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 K000215
Device Name SWIVEL ELBOW
Applicant
ENGINEERED MEDICAL SYSTEMS
2055 EXECUTIVE DR.
INDIANAPOLIS,  IN  46241
Applicant Contact BONNIE HOLLY
Correspondent
ENGINEERED MEDICAL SYSTEMS
2055 EXECUTIVE DR.
INDIANAPOLIS,  IN  46241
Correspondent Contact BONNIE HOLLY
Regulation Number868.5905
Classification Product Code
BZD  
Date Received01/24/2000
Decision Date 05/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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