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FDA 510(k)

CSI/MPR OR CSI/MPR PLUS

K-Number: K861852 · 1986-10-08

ApplicantColumbia Scientific, Inc.
Decision Date1986-10-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CSI/MPR OR CSI/MPR PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Columbia Scientific, Inc.. It received FDA 510(k) clearance on 1986-10-08 under 510(k) number K861852. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CSI/MPR OR CSI/MPR PLUS?

CSI/MPR OR CSI/MPR PLUS is a medical device that received FDA 510(k) clearance on 1986-10-08. The listed applicant is Columbia Scientific, Inc.. The 510(k) number is K861852.

When did CSI/MPR OR CSI/MPR PLUS receive FDA 510(k) clearance?

CSI/MPR OR CSI/MPR PLUS received FDA 510(k) clearance on 1986-10-08, under 510(k) number K861852.

Who is the listed applicant for CSI/MPR OR CSI/MPR PLUS?

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

What is the FDA product code for CSI/MPR OR CSI/MPR PLUS?

The FDA product code for CSI/MPR OR CSI/MPR PLUS is LLZ.

Other records listing Columbia Scientific, 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.

K011180CT/MASTER, VERSION 1.0K924810SIM/PLANTK897000IMAGEMASTER-101(TM)K8853223D/DENTALK880404CSI/QCTK870513CSI/3D

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Related Devices (Code: LLZ)

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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

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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