INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER

Catheter, Electrode Recording, Or Probe, Electrode Recording

IRVINE BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Irvine Biomedical, Inc. with the FDA for Inquiry Afocus, Inquiry Afocus Ii And Inquiry Optima Steerable Electrophysiology Catheter.

Pre-market Notification Details

Device IDK042775
510k NumberK042775
Device Name:INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER
ClassificationCatheter, Electrode Recording, Or Probe, Electrode Recording
Applicant IRVINE BIOMEDICAL, INC. 2375 MORSE AVE. Irvine,  CA  92614
ContactBonnie Bishop
CorrespondentBonnie Bishop
IRVINE BIOMEDICAL, INC. 2375 MORSE AVE. Irvine,  CA  92614
Product CodeDRF  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-10-06
Decision Date2004-11-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05414734311489 K042775 000
05414734311434 K042775 000
05414734311427 K042775 000
05414734305891 K042775 000
05414734305327 K042775 000
05414734305297 K042775 000
05414734305174 K042775 000
05414734305150 K042775 000
05414734304986 K042775 000

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