NUVANT MCT SYSTEM

Detector And Alarm, Arrhythmia

CORVENTIS, INC.

The following data is part of a premarket notification filed by Corventis, Inc. with the FDA for Nuvant Mct System.

Pre-market Notification Details

Device IDK133701
510k NumberK133701
Device Name:NUVANT MCT SYSTEM
ClassificationDetector And Alarm, Arrhythmia
Applicant CORVENTIS, INC. 1410 ENERGY PARK DRIVE, SUITE 1 St. Paul,  MN  55108
ContactCheryl Swanson
CorrespondentCheryl Swanson
CORVENTIS, INC. 1410 ENERGY PARK DRIVE, SUITE 1 St. Paul,  MN  55108
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-03
Decision Date2014-02-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169513686 K133701 000
00763000057152 K133701 000
00763000057176 K133701 000
00763000057190 K133701 000
00763000057206 K133701 000
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00763000065638 K133701 000
00763000065645 K133701 000
00763000065652 K133701 000
00763000065669 K133701 000
00763000065737 K133701 000
00763000065744 K133701 000
00643169513570 K133701 000
00643169513600 K133701 000
00643169513631 K133701 000
00643169513648 K133701 000
00643169513655 K133701 000
00763000057138 K133701 000

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