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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 K884089
Device Name ERA 2000 EMERGENCY RESUSCITATOR
Applicant
NEOTRONICS MEDICAL LTD.
PARSONAGE ROAD
BISHOP'S STORTFORD,  GB
Applicant Contact STAN CHERRY
Correspondent
NEOTRONICS MEDICAL LTD.
PARSONAGE ROAD
BISHOP'S STORTFORD,  GB
Correspondent Contact STAN CHERRY
Regulation Number868.5925
Classification Product Code
BTL  
Date Received09/28/1988
Decision Date 12/20/1988
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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