Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)

Endoscope, Neurological

Rebound Therapeutics

The following data is part of a premarket notification filed by Rebound Therapeutics with the FDA for Aurora Surgiscope System (surgiscope), Aurora Surgiscope System (image Control Box).

Pre-market Notification Details

Device IDK201840
510k NumberK201840
Device Name:Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
ClassificationEndoscope, Neurological
Applicant Rebound Therapeutics 13900 Alton Parkway Suite 120 Irvine,  CA  92618
ContactNaomi Gong
CorrespondentNaomi Gong
Rebound Therapeutics 13900 Alton Parkway Suite 120 Irvine,  CA  92618
Product CodeGWG  
CFR Regulation Number882.1480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-02
Decision Date2020-11-04

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