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FDA 510(k)

CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK

K-Number: K093389 · 2009-11-17

ApplicantComputerized Screening, Inc.
Decision Date2009-11-17
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK 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 2009-11-17 under 510(k) number K093389. 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 MODEL 5K MANAGED HEALTH SYSTEM KIOSK?

CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK is a medical device that received FDA 510(k) clearance on 2009-11-17. The listed applicant is Computerized Screening, Inc.. The 510(k) number is K093389.

When did CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK receive FDA 510(k) clearance?

CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK received FDA 510(k) clearance on 2009-11-17, under 510(k) number K093389.

Who is the listed applicant for CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK?

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 MODEL 5K MANAGED HEALTH SYSTEM KIOSK?

The FDA product code for CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK is DXN.

Related Clinical Trials

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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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.

K101198CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K

Related Devices (Code: DXN)

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

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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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