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FDA 510(k)

PHILIPS IU22 ULTRASOUND SYSTEM

K-Number: K042540 · 2004-10-04

ApplicantPhilips Ultrasound, Inc.
Decision Date2004-10-04
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHILIPS IU22 ULTRASOUND SYSTEM 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 2004-10-04 under 510(k) number K042540. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHILIPS IU22 ULTRASOUND SYSTEM?

PHILIPS IU22 ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2004-10-04. The listed applicant is Philips Ultrasound, Inc.. The 510(k) number is K042540.

When did PHILIPS IU22 ULTRASOUND SYSTEM receive FDA 510(k) clearance?

PHILIPS IU22 ULTRASOUND SYSTEM received FDA 510(k) clearance on 2004-10-04, under 510(k) number K042540.

Who is the listed applicant for PHILIPS IU22 ULTRASOUND SYSTEM?

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 PHILIPS IU22 ULTRASOUND SYSTEM?

The FDA product code for PHILIPS IU22 ULTRASOUND SYSTEM is IYO.

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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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