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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Blood-Pressure, Extravascular
510(k) Number K811538
Device Name MODELS TA 1017 & 1017T GRITIFLO DISPOS
Applicant
Gould, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Applicant Contact none none
Correspondent
Gould, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent Contact none none
Regulation Number870.2850
Classification Product Code
DRS  
Date Received06/01/1981
Decision Date 06/12/1981
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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