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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K943402
Device Name K.P.R. (KING PERSONAL RESUSCITATOR)
Applicant
King Systems Corp.
15011 Herriman Blvd.
P.O. Box 1138
Noblesville,  IN  46060
Applicant Contact MICHAEL A LEAGRE
Correspondent
King Systems Corp.
15011 Herriman Blvd.
P.O. Box 1138
Noblesville,  IN  46060
Correspondent Contact MICHAEL A LEAGRE
Regulation Number868.5870
Classification Product Code
CBP  
Date Received07/14/1994
Decision Date 08/19/1994
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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