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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, Manual (Resuscitator)
510(k) Number K152931
Device Name Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator
Applicant
AMBU A/S
BALTORPBAKKEN 13
BALLERUP,  DK DK-2750
Applicant Contact LINE KAGENOW SVENSTRUP
Correspondent
AMBU INC.
6230 OLD DOBBIN LANE, SUITE 250
COLUMBIA,  MD  21045
Correspondent Contact SANJAY PARIKH
Regulation Number868.5915
Classification Product Code
BTM  
Date Received10/05/2015
Decision Date 08/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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