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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 K871985
Device Name BEAR JET VENTILATOR FOR USE DURING (ESWL)
Applicant
Bear Medical Systems, Inc.
2085 Rustin Ave.
Riverside,  CA  92507
Applicant Contact RAY PIZINGER
Correspondent
Bear Medical Systems, Inc.
2085 Rustin Ave.
Riverside,  CA  92507
Correspondent Contact RAY PIZINGER
Regulation Number868.5895
Classification Product Code
CBK  
Date Received05/22/1987
Decision Date 06/15/1987
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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