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FDA 510(k)

McKesson Cardiology

K-Number: K181080 · 2018-05-24

ApplicantChange Healthcare Israel , Ltd.
Decision Date2018-05-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

McKesson Cardiology is the device name listed in this FDA 510(k) record. The listed applicant is Change Healthcare Israel , Ltd.. It received FDA 510(k) clearance on 2018-05-24 under 510(k) number K181080. 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 McKesson Cardiology?

McKesson Cardiology is a medical device that received FDA 510(k) clearance on 2018-05-24. The listed applicant is Change Healthcare Israel , Ltd.. The 510(k) number is K181080.

When did McKesson Cardiology receive FDA 510(k) clearance?

McKesson Cardiology received FDA 510(k) clearance on 2018-05-24, under 510(k) number K181080.

Who is the listed applicant for McKesson Cardiology?

The FDA 510(k) record lists Change Healthcare Israel , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for McKesson Cardiology?

The FDA product code for McKesson Cardiology is LLZ.

Other records listing Change Healthcare Israel , Ltd. 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.

K230881Change Healthcare Cardiology Hemodynamics™K212528Change Healthcare Cardiology

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.

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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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