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FDA 510(k)

UST-5268P-5 TRANSDUCER

K-Number: K950607 · 1995-09-15

ApplicantAloka Co., Ltd.
Decision Date1995-09-15
Product CodeKRK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UST-5268P-5 TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Aloka Co., Ltd.. It received FDA 510(k) clearance on 1995-09-15 under 510(k) number K950607. The device is classified under product code KRK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UST-5268P-5 TRANSDUCER?

UST-5268P-5 TRANSDUCER is a medical device that received FDA 510(k) clearance on 1995-09-15. The listed applicant is Aloka Co., Ltd.. The 510(k) number is K950607.

When did UST-5268P-5 TRANSDUCER receive FDA 510(k) clearance?

UST-5268P-5 TRANSDUCER received FDA 510(k) clearance on 1995-09-15, under 510(k) number K950607.

Who is the listed applicant for UST-5268P-5 TRANSDUCER?

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

What is the FDA product code for UST-5268P-5 TRANSDUCER?

The FDA product code for UST-5268P-5 TRANSDUCER is KRK.

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Other records listing Aloka Co., 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.

K111227ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEMK110207ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEMK093488ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEMK083254ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEMK081843ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1K080176ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM

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Related Devices (Code: KRK)

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.

K904674CENTRAL VENOUS PRESSURE MANOMETERMedex, Inc.K884386ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCKEthitek Pharmaceuticals Co.K875322MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETERSchneider-Shilley (Usa)K861605SCHNEIDER-SHILEY PRESSURE MANOMETERShiley, Inc.K830910MANOMETER SET C.V.P. #S 298/299Exco, Inc.K813498MEDIFIXBurron Medical Products, Inc.

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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