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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K011516
Device Name INFANT FLOW SYSTEM, MODEL M672P
Applicant
EME (ELECTRO MEDICAL EQUIPMENT) LTD.
60 GLADSTONE PLACE
BRIGHTON, SUSSEX,  GB BN2 3QD
Applicant Contact STUART CORNER
Correspondent
EME (ELECTRO MEDICAL EQUIPMENT) LTD.
60 GLADSTONE PLACE
BRIGHTON, SUSSEX,  GB BN2 3QD
Correspondent Contact STUART CORNER
Regulation Number868.5905
Classification Product Code
BZD  
Date Received05/17/2001
Decision Date 06/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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