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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 K131877
Device Name SAVE II, SAVE II BASIC
Applicant
AUTOMEDX INC.
1420 Lakeside Parkway, Suite 102
Flower Mound,  TX  75028
Applicant Contact PAUL DRYDEN
Correspondent
AUTOMEDX INC.
1420 Lakeside Parkway, Suite 102
Flower Mound,  TX  75028
Correspondent Contact PAUL DRYDEN
Regulation Number868.5925
Classification Product Code
BTL  
Date Received06/25/2013
Decision Date 03/21/2014
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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