FDA 510(k)

DUNLEE FORMAT COLLIMATOR FAMILY

K-Number: K031597 · 2003-07-21

ApplicantPhilips Medical Systems North America Co.

Decision Date2003-07-21

Product CodeIZW

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DUNLEE FORMAT COLLIMATOR FAMILY is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems North America Co.. It received FDA 510(k) clearance on 2003-07-21 under 510(k) number K031597. The device is classified under product code IZW. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUNLEE FORMAT COLLIMATOR FAMILY?

DUNLEE FORMAT COLLIMATOR FAMILY is a medical device that received FDA 510(k) clearance on 2003-07-21. The listed applicant is Philips Medical Systems North America Co.. The 510(k) number is K031597.

When did DUNLEE FORMAT COLLIMATOR FAMILY receive FDA 510(k) clearance?

DUNLEE FORMAT COLLIMATOR FAMILY received FDA 510(k) clearance on 2003-07-21, under 510(k) number K031597.

Who is the listed applicant for DUNLEE FORMAT COLLIMATOR FAMILY?

The FDA 510(k) record lists Philips Medical Systems North America Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUNLEE FORMAT COLLIMATOR FAMILY?

The FDA product code for DUNLEE FORMAT COLLIMATOR FAMILY is IZW.

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Related Devices (Code: IZW)

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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.