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FDA 510(k)

HUGH YOUNG II UROLOGICAL X-RAY SYSTEM

K-Number: K904147 · 1990-12-13

ApplicantMallinckrodt Group, Inc.
Decision Date1990-12-13
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HUGH YOUNG II UROLOGICAL X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Group, Inc.. It received FDA 510(k) clearance on 1990-12-13 under 510(k) number K904147. 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 HUGH YOUNG II UROLOGICAL X-RAY SYSTEM?

HUGH YOUNG II UROLOGICAL X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 1990-12-13. The listed applicant is Mallinckrodt Group, Inc.. The 510(k) number is K904147.

When did HUGH YOUNG II UROLOGICAL X-RAY SYSTEM receive FDA 510(k) clearance?

HUGH YOUNG II UROLOGICAL X-RAY SYSTEM received FDA 510(k) clearance on 1990-12-13, under 510(k) number K904147.

Who is the listed applicant for HUGH YOUNG II UROLOGICAL X-RAY SYSTEM?

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

What is the FDA product code for HUGH YOUNG II UROLOGICAL X-RAY SYSTEM?

The FDA product code for HUGH YOUNG II UROLOGICAL X-RAY SYSTEM is KPR.

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Other records listing Mallinckrodt Group, Inc. 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.

K945053LF CT HIG PRESSURE CATHETERSK945140URO-FLOK943581HYDRADJUST IV UROLOGICAL TABLEK943122SURGICAL DRAPESK934664HYDRAGOWNK920742HYDRAJUST IV UROLOGICAL TABLE

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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

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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