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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K810561
Device Name DOPSCAN MODEL 1050
Applicant
Carolina Medical Electronics
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Carolina Medical Electronics
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.2100
Classification Product Code
DPW  
Date Received03/03/1981
Decision Date 04/10/1981
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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