SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER

Computer, Diagnostic, Programmable

ELA MEDICAL INC

The following data is part of a premarket notification filed by Ela Medical Inc with the FDA for Synescope, Easyscope, Synecom, Holterreader.

Pre-market Notification Details

Device IDK042002
510k NumberK042002
Device Name:SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER
ClassificationComputer, Diagnostic, Programmable
Applicant ELA MEDICAL INC 2950 XENIUM LN. N. STE. 120 Plymouth,  MN  55441
ContactSusan Olive
CorrespondentSusan Olive
ELA MEDICAL INC 2950 XENIUM LN. N. STE. 120 Plymouth,  MN  55441
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-26
Decision Date2004-10-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08031527015040 K042002 000
08031527015033 K042002 000
08031527014944 K042002 000
08031527014913 K042002 000
08031527014296 K042002 000
08031527014289 K042002 000
08031527013435 K042002 000

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