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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 K092085
Device Name ISPIRA RESUSCITATION UNIT
Applicant
NEOFORCE GROUP, INC.
35 COMMERCE DR.
IVYLAND,  PA  18974
Applicant Contact MONICA FERRANTE
Correspondent
NEOFORCE GROUP, INC.
35 COMMERCE DR.
IVYLAND,  PA  18974
Correspondent Contact MONICA FERRANTE
Regulation Number868.5925
Classification Product Code
BTL  
Date Received07/09/2009
Decision Date 10/07/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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