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FDA 510(k)

UNFORS PATIENT SKIN DOSIMETER (PSD)

K-Number: K042698 · 2004-10-22

ApplicantUnfors, Inc.
Decision Date2004-10-22
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UNFORS PATIENT SKIN DOSIMETER (PSD) is the device name listed in this FDA 510(k) record. The listed applicant is Unfors, Inc.. It received FDA 510(k) clearance on 2004-10-22 under 510(k) number K042698. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNFORS PATIENT SKIN DOSIMETER (PSD)?

UNFORS PATIENT SKIN DOSIMETER (PSD) is a medical device that received FDA 510(k) clearance on 2004-10-22. The listed applicant is Unfors, Inc.. The 510(k) number is K042698.

When did UNFORS PATIENT SKIN DOSIMETER (PSD) receive FDA 510(k) clearance?

UNFORS PATIENT SKIN DOSIMETER (PSD) received FDA 510(k) clearance on 2004-10-22, under 510(k) number K042698.

Who is the listed applicant for UNFORS PATIENT SKIN DOSIMETER (PSD)?

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

What is the FDA product code for UNFORS PATIENT SKIN DOSIMETER (PSD)?

The FDA product code for UNFORS PATIENT SKIN DOSIMETER (PSD) is JAA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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