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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 K964719
Device Name HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR
Applicant
Hudson Respiratory Care, Inc.
27711 Diaz Rd.
P.O. Box 9020
Temecula,  CA  92589 -9020
Applicant Contact ARDEN P MORLEY
Correspondent
Hudson Respiratory Care, Inc.
27711 Diaz Rd.
P.O. Box 9020
Temecula,  CA  92589 -9020
Correspondent Contact ARDEN P MORLEY
Regulation Number868.5915
Classification Product Code
BTM  
Date Received11/25/1996
Decision Date 02/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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