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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 K913714
Device Name MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)
Applicant
Life Design Systems, Inc.
2735 E. Beltline Rd.
Carrollton,  TX  75006
Applicant Contact JAMES ANTOSH
Correspondent
Life Design Systems, Inc.
2735 E. Beltline Rd.
Carrollton,  TX  75006
Correspondent Contact JAMES ANTOSH
Regulation Number868.5915
Classification Product Code
BTM  
Date Received08/15/1991
Decision Date 12/01/1992
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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