TABLET COMMANDER

Transmitters And Receivers, Physiological Signal, Radiofrequency

CARDIOCOM LLC

The following data is part of a premarket notification filed by Cardiocom Llc with the FDA for Tablet Commander.

Pre-market Notification Details

Device IDK122285
510k NumberK122285
Device Name:TABLET COMMANDER
ClassificationTransmitters And Receivers, Physiological Signal, Radiofrequency
Applicant CARDIOCOM LLC 7980 CENTURY BLVD. Chanhassen,  MN  55317
ContactDaniel L Cosentino
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeDRG  
CFR Regulation Number870.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2012-07-30
Decision Date2012-08-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000001964 K122285 000

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