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FDA 510(k)

UST-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35

K-Number: K922549 · 1992-09-21

ApplicantAloka Co., Ltd.
Decision Date1992-09-21
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UST-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35 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 1992-09-21 under 510(k) number K922549. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UST-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35?

UST-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35 is a medical device that received FDA 510(k) clearance on 1992-09-21. The listed applicant is Aloka Co., Ltd.. The 510(k) number is K922549.

When did UST-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35 receive FDA 510(k) clearance?

UST-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35 received FDA 510(k) clearance on 1992-09-21, under 510(k) number K922549.

Who is the listed applicant for UST-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35?

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-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35?

The FDA product code for UST-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35 is ITX.

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: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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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