MODEL 405

Electrocardiograph

IVY BIOMEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Model 405.

Pre-market Notification Details

Device IDK904606
510k NumberK904606
Device Name:MODEL 405
ClassificationElectrocardiograph
Applicant IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford,  CT  06405
ContactM Simon
CorrespondentM Simon
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 Received1990-10-10
Decision Date1991-03-01

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