MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR

Transducer, Blood-pressure, Extravascular

GOULD, INC.

The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Model:ta-rose Resonant Overshoot Eliminator.

Pre-market Notification Details

Device IDK855145
510k NumberK855145
Device Name:MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR
ClassificationTransducer, Blood-pressure, Extravascular
Applicant GOULD, INC. 1900 WILLIAMS DR. Oxnard,  CA  93030
ContactGordon Ph.d.
CorrespondentGordon Ph.d.
GOULD, INC. 1900 WILLIAMS DR. Oxnard,  CA  93030
Product CodeDRS  
CFR Regulation Number870.2850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-24
Decision Date1986-02-26

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