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FDA 510(k)

QLAB QUANTIFICATION SOFTWARE HEART MODEL

K-Number: K130159 · 2013-05-13

ApplicantPhilips Health Care
Decision Date2013-05-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QLAB QUANTIFICATION SOFTWARE HEART MODEL is the device name listed in this FDA 510(k) record. The listed applicant is Philips Health Care. It received FDA 510(k) clearance on 2013-05-13 under 510(k) number K130159. 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 QLAB QUANTIFICATION SOFTWARE HEART MODEL?

QLAB QUANTIFICATION SOFTWARE HEART MODEL is a medical device that received FDA 510(k) clearance on 2013-05-13. The listed applicant is Philips Health Care. The 510(k) number is K130159.

When did QLAB QUANTIFICATION SOFTWARE HEART MODEL receive FDA 510(k) clearance?

QLAB QUANTIFICATION SOFTWARE HEART MODEL received FDA 510(k) clearance on 2013-05-13, under 510(k) number K130159.

Who is the listed applicant for QLAB QUANTIFICATION SOFTWARE HEART MODEL?

The FDA 510(k) record lists Philips Health Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QLAB QUANTIFICATION SOFTWARE HEART MODEL?

The FDA product code for QLAB QUANTIFICATION SOFTWARE HEART MODEL is LLZ.

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Other records listing Philips Health Care 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: 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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