Real Intelligence Cori

Orthopedic Stereotaxic Instrument

Blue Belt Technologies, Inc.

The following data is part of a premarket notification filed by Blue Belt Technologies, Inc. with the FDA for Real Intelligence Cori.

Pre-market Notification Details

Device IDK220958
510k NumberK220958
Device Name:Real Intelligence Cori
ClassificationOrthopedic Stereotaxic Instrument
Applicant Blue Belt Technologies, Inc. 2905 Northwest Blvd., Ste. 40 Plymouth,  MN  55441
ContactUnnati Bhuptani
CorrespondentUnnati Bhuptani
Blue Belt Technologies, Inc. 2905 Northwest Blvd., Ste. 40 Plymouth,  MN  55441
Product CodeOLO  
Subsequent Product CodeHSX
Subsequent Product CodeJWH
Subsequent Product CodeMBH
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-01
Decision Date2022-07-27

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