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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 K910201
Device Name LIFE O2
Applicant
Life Corp.
P.O. Box 300
W140 N5566 Lilly Rd.
Menomonee Falls,  WI  53051
Applicant Contact JOHN KIRCHGEORG
Correspondent
Life Corp.
P.O. Box 300
W140 N5566 Lilly Rd.
Menomonee Falls,  WI  53051
Correspondent Contact JOHN KIRCHGEORG
Regulation Number868.5925
Classification Product Code
BTL  
Date Received01/18/1991
Decision Date 02/01/1991
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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