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FDA 510(k)

CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K

K-Number: K101198 · 2010-08-04

ApplicantComputerized Screening, Inc.
Decision Date2010-08-04
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K is the device name listed in this FDA 510(k) record. The listed applicant is Computerized Screening, Inc.. It received FDA 510(k) clearance on 2010-08-04 under 510(k) number K101198. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K?

CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K is a medical device that received FDA 510(k) clearance on 2010-08-04. The listed applicant is Computerized Screening, Inc.. The 510(k) number is K101198.

When did CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K receive FDA 510(k) clearance?

CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K received FDA 510(k) clearance on 2010-08-04, under 510(k) number K101198.

Who is the listed applicant for CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K?

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

What is the FDA product code for CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K?

The FDA product code for CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K is DXN.

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Other records listing Computerized Screening, 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.

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Related Devices (Code: DXN)

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Official Source

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

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