MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR

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 Model 303d And 403d Adult Heart Rate & Respirator.

Pre-market Notification Details

Device IDK880066
510k NumberK880066
Device Name:MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR
ClassificationMonitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
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 CodeDRT  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-01-11
Decision Date1988-03-22

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