PHYSIOLOGICAL MONITOR, MODELS 101,301,201,202,303A

Electrocardiograph

IVY BIOMEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Physiological Monitor, Models 101,301,201,202,303a.

Pre-market Notification Details

Device IDK854840
510k NumberK854840
Device Name:PHYSIOLOGICAL MONITOR, MODELS 101,301,201,202,303A
ClassificationElectrocardiograph
Applicant IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford,  CT  06405
ContactRichard A Mentelos
CorrespondentRichard A Mentelos
IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford,  CT  06405
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-04
Decision Date1986-05-07

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