OMNI-TRAK PATIENT MONITORING SYSTEM

Electrocardiograph

INVIVO RESEARCH, INC.

The following data is part of a premarket notification filed by Invivo Research, Inc. with the FDA for Omni-trak Patient Monitoring System.

Pre-market Notification Details

Device IDK955045
510k NumberK955045
Device Name:OMNI-TRAK PATIENT MONITORING SYSTEM
ClassificationElectrocardiograph
Applicant INVIVO RESEARCH, INC. 12601 RESEARCH PKWY. Orlando,  FL  32826
ContactFrancis X Casey
CorrespondentFrancis X Casey
INVIVO RESEARCH, INC. 12601 RESEARCH PKWY. Orlando,  FL  32826
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-03
Decision Date1996-07-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838016002 K955045 000
20884838029525 K955045 000

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