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FDA 510(k)

ALARIS PC UNIT, MODELS 8000 AND 8015

K-Number: K091308 · 2009-07-09

ApplicantCardinal Health 303,Inc.
Decision Date2009-07-09
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ALARIS PC UNIT, MODELS 8000 AND 8015 is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health 303,Inc.. It received FDA 510(k) clearance on 2009-07-09 under 510(k) number K091308. 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 PC UNIT, MODELS 8000 AND 8015?

ALARIS PC UNIT, MODELS 8000 AND 8015 is a medical device that received FDA 510(k) clearance on 2009-07-09. The listed applicant is Cardinal Health 303,Inc.. The 510(k) number is K091308.

When did ALARIS PC UNIT, MODELS 8000 AND 8015 receive FDA 510(k) clearance?

ALARIS PC UNIT, MODELS 8000 AND 8015 received FDA 510(k) clearance on 2009-07-09, under 510(k) number K091308.

Who is the listed applicant for ALARIS PC UNIT, MODELS 8000 AND 8015?

The FDA 510(k) record lists Cardinal Health 303,Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALARIS PC UNIT, MODELS 8000 AND 8015?

The FDA product code for ALARIS PC UNIT, MODELS 8000 AND 8015 is FRN.

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Other records listing Cardinal Health 303,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: 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

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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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