MODELS TA 1017 & 1017T GRITIFLO DISPOS

Transducer, Blood-pressure, Extravascular

GOULD, INC.

The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Models Ta 1017 & 1017t Gritiflo Dispos.

Pre-market Notification Details

Device IDK811538
510k NumberK811538
Device Name:MODELS TA 1017 & 1017T GRITIFLO DISPOS
ClassificationTransducer, Blood-pressure, Extravascular
Applicant GOULD, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
ContactNone None
CorrespondentNone None
GOULD, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDRS  
CFR Regulation Number870.2850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-06-01
Decision Date1981-06-12

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