REAL INTELLIGENCE CORI (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 (cori).

Pre-market Notification Details

Device IDK201022
510k NumberK201022
Device Name:REAL INTELLIGENCE CORI (CORI)
ClassificationOrthopedic Stereotaxic Instrument
Applicant Blue Belt Technologies, Inc. 2905 Northwest Blvd., Ste. 40 Plymouth,  MN  55441
ContactCorrine Herlinger
CorrespondentCorrine Herlinger
Blue Belt Technologies, Inc. 2905 Northwest Blvd., Ste. 40 Plymouth,  MN  55441
Product CodeOLO  
Subsequent Product CodeHRY
Subsequent Product CodeHSX
Subsequent Product CodeNPJ
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-20
Decision Date2020-06-12

NIH GUDID Devices

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