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 IDK212537
510k NumberK212537
Device Name:REAL INTELLIGENCE CORI (CORI)
ClassificationOrthopedic Stereotaxic Instrument
Applicant Blue Belt Technologies, Inc. 2905 Northwest Blvd., Ste. 40 Plymouth,  MN  55441
ContactSarah Plittman
CorrespondentSarah Plittman
Blue Belt Technologies, Inc. 2905 Northwest Blvd., Ste. 40 Plymouth,  MN  55441
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-12
Decision Date2021-11-03

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