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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Impedance
510(k) Number K914200
Device Name VASCUMAP MEDICAL AIR PLETHYSMOGRAPH
Applicant
Carolina Medical Electronics
P. O. Box 307
King,  NC  27021
Applicant Contact JAMES S CAMPBELL
Correspondent
Carolina Medical Electronics
P. O. Box 307
King,  NC  27021
Correspondent Contact JAMES S CAMPBELL
Regulation Number870.2770
Classification Product Code
DSB  
Date Received09/19/1991
Decision Date 11/07/1991
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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