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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 K885243
Device Name NEOVO2R VENTILATORY
Applicant
NEOMED
1734 OXFORD STREET, EAST
UNIT E9, LONDON, ONTARIO
CANADA, N5V 3R6,  GB
Applicant Contact ROBERT KELLY
Correspondent
NEOMED
1734 OXFORD STREET, EAST
UNIT E9, LONDON, ONTARIO
CANADA, N5V 3R6,  GB
Correspondent Contact ROBERT KELLY
Regulation Number868.5915
Classification Product Code
BTM  
Date Received12/22/1988
Decision Date 07/24/1989
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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