RTR-2000/RTR-4000

System, X-ray, Tomography, Computed

TERARECON, INC.

The following data is part of a premarket notification filed by Terarecon, Inc. with the FDA for Rtr-2000/rtr-4000.

Pre-market Notification Details

Device IDK974307
510k NumberK974307
Device Name:RTR-2000/RTR-4000
ClassificationSystem, X-ray, Tomography, Computed
Applicant TERARECON, INC. 280 UTAH AVE., SUITE 100 South San Francisco,  CA  94080
ContactTim Frandsen
CorrespondentTim Frandsen
TERARECON, INC. 280 UTAH AVE., SUITE 100 South San Francisco,  CA  94080
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-11-17
Decision Date1998-02-13
Summary:summary

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