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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 Rd.
Bishop'S Stortford,  GB
Applicant Contact STAN CHERRY
Correspondent
Neotronics Medical , Ltd.
Parsonage Rd.
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
Predetermined Change
Control Plan Authorized		 No
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