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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 K132172
Device Name NEONATALIE RESUSCITATOR
Applicant
LAERDAL MEDICAL A/S
TANKE SVILANDSGT. 30
STAVANGER,  NO N-4000
Applicant Contact MARI KAADA
Correspondent
LAERDAL MEDICAL A/S
TANKE SVILANDSGT. 30
STAVANGER,  NO N-4000
Correspondent Contact MARI KAADA
Regulation Number868.5915
Classification Product Code
BTM  
Date Received07/15/2013
Decision Date 01/15/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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