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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 K910699
Device Name LIFE-02 (NON-REFILLABLE CYLINDER)
Applicant
Life Corp.
P.O. Box 300
W140 N5566 Lilly Rd.
Menomonee Falls,  WI  53051
Applicant Contact JOHN KIRCHGERORG
Correspondent
Life Corp.
P.O. Box 300
W140 N5566 Lilly Rd.
Menomonee Falls,  WI  53051
Correspondent Contact JOHN KIRCHGERORG
Regulation Number868.5925
Classification Product Code
BTL  
Date Received02/19/1991
Decision Date 06/18/1991
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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