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FDA 510(k)

ALARIS SYSTEM PC UNIT, MODEL 8001

K-Number: K051641 · 2005-10-20

ApplicantCardinal Health, Alaris Products
Decision Date2005-10-20
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ALARIS SYSTEM PC UNIT, MODEL 8001 is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health, Alaris Products. It received FDA 510(k) clearance on 2005-10-20 under 510(k) number K051641. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALARIS SYSTEM PC UNIT, MODEL 8001?

ALARIS SYSTEM PC UNIT, MODEL 8001 is a medical device that received FDA 510(k) clearance on 2005-10-20. The listed applicant is Cardinal Health, Alaris Products. The 510(k) number is K051641.

When did ALARIS SYSTEM PC UNIT, MODEL 8001 receive FDA 510(k) clearance?

ALARIS SYSTEM PC UNIT, MODEL 8001 received FDA 510(k) clearance on 2005-10-20, under 510(k) number K051641.

Who is the listed applicant for ALARIS SYSTEM PC UNIT, MODEL 8001?

The FDA 510(k) record lists Cardinal Health, Alaris Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALARIS SYSTEM PC UNIT, MODEL 8001?

The FDA product code for ALARIS SYSTEM PC UNIT, MODEL 8001 is FRN.

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Other records listing Cardinal Health, Alaris Products 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: FRN)

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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