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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 K911261
Device Name ERA 2000A
Applicant
NEOTRONICS, INC.
P.O. BOX 370, 2144 HILTON DR.
SW
GAINESVILLE,  GA  30501
Applicant Contact JOE LAMBARDO
Correspondent
NEOTRONICS, INC.
P.O. BOX 370, 2144 HILTON DR.
SW
GAINESVILLE,  GA  30501
Correspondent Contact JOE LAMBARDO
Regulation Number868.5925
Classification Product Code
BTL  
Date Received03/22/1991
Decision Date 05/31/1991
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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