AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569

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 Afocus Electropysiology Catheter System, Models 81550, 81567, 81568, 81569.

Pre-market Notification Details

Device IDK010471
510k NumberK010471
Device Name:AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569
ClassificationCatheter, Electrode Recording, Or Probe, Electrode Recording
Applicant IRVINE BIOMEDICAL, INC. 2146-A MICHELSON DR. Irvine,  CA  92612
ContactJames Farnworth
CorrespondentJames Farnworth
IRVINE BIOMEDICAL, INC. 2146-A MICHELSON DR. Irvine,  CA  92612
Product CodeDRF  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-02-20
Decision Date2001-06-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05414734305303 K010471 000
05414734305273 K010471 000
05414734305235 K010471 000
05414734305228 K010471 000
05414734305051 K010471 000
05414734305020 K010471 000
05414734305013 K010471 000
05414734305006 K010471 000
05414734304962 K010471 000

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