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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 K811616
Device Name BACH-SIMPSON MODEL TS266
Applicant
Bach-Simpson , Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Bach-Simpson , Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.2100
Classification Product Code
DPW  
Date Received06/08/1981
Decision Date 08/13/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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