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FDA 510(k)

QLAB QUANTIFICATION

K-Number: K070792 · 2007-04-06

ApplicantPhilips Ultrasound, Inc.
Decision Date2007-04-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QLAB QUANTIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Philips Ultrasound, Inc.. It received FDA 510(k) clearance on 2007-04-06 under 510(k) number K070792. 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?

QLAB QUANTIFICATION is a medical device that received FDA 510(k) clearance on 2007-04-06. The listed applicant is Philips Ultrasound, Inc.. The 510(k) number is K070792.

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

QLAB QUANTIFICATION received FDA 510(k) clearance on 2007-04-06, under 510(k) number K070792.

Who is the listed applicant for QLAB QUANTIFICATION?

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

What is the FDA product code for QLAB QUANTIFICATION?

The FDA product code for QLAB QUANTIFICATION is LLZ.

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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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