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FDA 510(k)

REAL INTELLIGENCE™ CORI™

K-Number: K231963 · 2023-08-01

ApplicantBlue Belt Technologies, Inc.
Decision Date2023-08-01
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

REAL INTELLIGENCE™ CORI™ is the device name listed in this FDA 510(k) record. The listed applicant is Blue Belt Technologies, Inc.. It received FDA 510(k) clearance on 2023-08-01 under 510(k) number K231963. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAL INTELLIGENCE™ CORI™?

REAL INTELLIGENCE™ CORI™ is a medical device that received FDA 510(k) clearance on 2023-08-01. The listed applicant is Blue Belt Technologies, Inc.. The 510(k) number is K231963.

When did REAL INTELLIGENCE™ CORI™ receive FDA 510(k) clearance?

REAL INTELLIGENCE™ CORI™ received FDA 510(k) clearance on 2023-08-01, under 510(k) number K231963.

Who is the listed applicant for REAL INTELLIGENCE™ CORI™?

The FDA 510(k) record lists Blue Belt Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REAL INTELLIGENCE™ CORI™?

The FDA product code for REAL INTELLIGENCE™ CORI™ is OLO.

Other records listing Blue Belt Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260601REAL INTELLIGENCE™ CORI™K252841REAL INTELLIGENCE™ CORI™ XT (CORI XT)K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesK242272CORIOGRAPH Pre-Op Planning and Modeling ServicesK240139Real Intelligence™ CORI™K221224REAL INTELLIGENCE CORI

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Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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