PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)

Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

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, Model 3000 (series).

Pre-market Notification Details

Device IDK023616
510k NumberK023616
Device Name:PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)
ClassificationMonitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Applicant IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford,  CT  06405
ContactDick Listro
CorrespondentDick Listro
IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford,  CT  06405
Product CodeDRT  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-29
Decision Date2002-11-04

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