CARDIO METRICS INVASIVE PRESSURE MONIT

Transducer, Blood-pressure, Extravascular

STERILE DESIGN, INC.

The following data is part of a premarket notification filed by Sterile Design, Inc. with the FDA for Cardio Metrics Invasive Pressure Monit.

Pre-market Notification Details

Device IDK841960
510k NumberK841960
Device Name:CARDIO METRICS INVASIVE PRESSURE MONIT
ClassificationTransducer, Blood-pressure, Extravascular
Applicant STERILE DESIGN, INC. P.O. BOX 12100 Oldsmar,  FL  34677 -0137
Product CodeDRS  
CFR Regulation Number870.2850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-05-14
Decision Date1985-11-08

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