ROSETTA-LT/ROSETTA-RX

Transmitters And Receivers, Physiological Signal, Radiofrequency

GENERAL DEVICES

The following data is part of a premarket notification filed by General Devices with the FDA for Rosetta-lt/rosetta-rx.

Pre-market Notification Details

Device IDK002089
510k NumberK002089
Device Name:ROSETTA-LT/ROSETTA-RX
ClassificationTransmitters And Receivers, Physiological Signal, Radiofrequency
Applicant GENERAL DEVICES 1000 RIVER ST. Ridgefield,  NJ  07657
ContactMichael Smith
CorrespondentMichael Smith
GENERAL DEVICES 1000 RIVER ST. Ridgefield,  NJ  07657
Product CodeDRG  
CFR Regulation Number870.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-11
Decision Date2000-11-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00862186000386 K002089 000

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