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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
510(k) Number K863702
Device Name PULSE CUFF RECORDER MODEL PCR100
Applicant
Imex Medical Systems, Inc.
6355 Joyce Dr.
Golden,  CO  80403
Applicant Contact ED BISTRICK
Correspondent
Imex Medical Systems, Inc.
6355 Joyce Dr.
Golden,  CO  80403
Correspondent Contact ED BISTRICK
Regulation Number870.2780
Classification Product Code
JOM  
Date Received09/23/1986
Decision Date 06/12/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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