MODEL 700 PATIENT MONITOR

Transducer, Blood-pressure, Extravascular

IVY BIOMEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Model 700 Patient Monitor.

Pre-market Notification Details

Device IDK882118
510k NumberK882118
Device Name:MODEL 700 PATIENT MONITOR
ClassificationTransducer, Blood-pressure, Extravascular
Applicant IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford,  CT  06405
ContactBrenda E Lundy
CorrespondentBrenda E Lundy
IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford,  CT  06405
Product CodeDRS  
CFR Regulation Number870.2850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-05-19
Decision Date1988-08-02

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