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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K874692
Device Name PULSEMATE BX-5
Applicant
Colin Medical Instruments Corp.
1330 Connecticut Ave., NW
Washington,  DC  20036
Applicant Contact EDWARD M LEBOW
Correspondent
Colin Medical Instruments Corp.
1330 Connecticut Ave., NW
Washington,  DC  20036
Correspondent Contact EDWARD M LEBOW
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/16/1987
Decision Date 02/02/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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