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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K983981
Device Name BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE
Applicant
Bear Medical Systems, Inc.
1100 Bird Center Dr.
Palm Spring,  CA  92262
Applicant Contact DARRYL SHELBY
Correspondent
Bear Medical Systems, Inc.
1100 Bird Center Dr.
Palm Spring,  CA  92262
Correspondent Contact DARRYL SHELBY
Regulation Number868.5895
Classification Product Code
CBK  
Date Received11/09/1998
Decision Date 11/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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