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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, emergency, powered (resuscitator)
510(k) Number K071221
Device Name SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12
Applicant
AUTOMEDX INC.
12321 MIDDLEBROOK RD
SUITE 150
GERMANTOWN,  MD  20874
Applicant Contact JAMES D EVANS
Correspondent
AUTOMEDX INC.
12321 MIDDLEBROOK RD
SUITE 150
GERMANTOWN,  MD  20874
Correspondent Contact JAMES D EVANS
Regulation Number868.5925
Classification Product Code
BTL  
Date Received05/02/2007
Decision Date 09/06/2007
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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