GENESIS DM MODEL: 6053000A1

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 Dm Model: 6053000a1.

Pre-market Notification Details

Device IDK101242
510k NumberK101242
Device Name:GENESIS DM MODEL: 6053000A1
ClassificationTransmitters And Receivers, Physiological Signal, Radiofrequency
Applicant HONEYWELL HOMMED, LLC 3400 INTERTECH DR. SUITE 200 Brookfield,  WI  53045
ContactEmily Hei
CorrespondentEmily Hei
HONEYWELL HOMMED, LLC 3400 INTERTECH DR. SUITE 200 Brookfield,  WI  53045
Product CodeDRG  
CFR Regulation Number870.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-05-03
Decision Date2010-06-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817644020123 K101242 000
00817644020116 K101242 000
00817644020048 K101242 000

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