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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
Predetermined Change
Control Plan Authorized		 No
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