FDA 510(k)

WBR-FHR, WBR-FWB

K-Number: K040370 · 2004-03-11

Decision Date2004-03-11

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

WBR-FHR, WBR-FWB is the device name listed in this FDA 510(k) record. The listed applicant is Ultraspect , Ltd.. It received FDA 510(k) clearance on 2004-03-11 under 510(k) number K040370. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WBR-FHR, WBR-FWB?

WBR-FHR, WBR-FWB is a medical device that received FDA 510(k) clearance on 2004-03-11. The listed applicant is Ultraspect , Ltd.. The 510(k) number is K040370.

When did WBR-FHR, WBR-FWB receive FDA 510(k) clearance?

WBR-FHR, WBR-FWB received FDA 510(k) clearance on 2004-03-11, under 510(k) number K040370.

Who is the listed applicant for WBR-FHR, WBR-FWB?

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

What is the FDA product code for WBR-FHR, WBR-FWB?

The FDA product code for WBR-FHR, WBR-FWB is KPS.

Other records listing Ultraspect , Ltd. 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.

K103710WBR XPRESS PET K091073WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS K081201WBR XPRESS3.CARDIAC K080784WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE K050815XACT.CARDIAC & XPRESS.CARDIAC

Related Devices (Code: KPS)

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.