GENESIS OTC MONITOR

Transmitters And Receivers, Physiological Signal, Radiofrequency

HONEYWELL HOMMED, LLC

The following data is part of a premarket notification filed by Honeywell Hommed, Llc with the FDA for Genesis Otc Monitor.

Pre-market Notification Details

Device IDK061087
510k NumberK061087
Device Name:GENESIS OTC MONITOR
ClassificationTransmitters And Receivers, Physiological Signal, Radiofrequency
Applicant HONEYWELL HOMMED, LLC 2018 NORTH DURHAM DRIVE Houston,  TX  77008
ContactTommie J Morgan
CorrespondentTommie J Morgan
HONEYWELL HOMMED, LLC 2018 NORTH DURHAM DRIVE Houston,  TX  77008
Product CodeDRG  
CFR Regulation Number870.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-18
Decision Date2006-06-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817644020109 K061087 000
00817644020093 K061087 000
00817644020086 K061087 000

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