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FDA 510(k)

PXI URCD

K-Number: K913435 · 1992-11-05

ApplicantBrotherston/Pxi
Decision Date1992-11-05
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PXI URCD is the device name listed in this FDA 510(k) record. The listed applicant is Brotherston/Pxi. It received FDA 510(k) clearance on 1992-11-05 under 510(k) number K913435. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PXI URCD?

PXI URCD is a medical device that received FDA 510(k) clearance on 1992-11-05. The listed applicant is Brotherston/Pxi. The 510(k) number is K913435.

When did PXI URCD receive FDA 510(k) clearance?

PXI URCD received FDA 510(k) clearance on 1992-11-05, under 510(k) number K913435.

Who is the listed applicant for PXI URCD?

The FDA 510(k) record lists Brotherston/Pxi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PXI URCD?

The FDA product code for PXI URCD is KPR.

Other records listing Brotherston/Pxi 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.

K913436PXI PNEUMATIC COMPRESSION PADDLE

Related Devices (Code: KPR)

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.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

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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