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FDA 510(k)

LINEAR ARRAY TRANSDUCER OR SCANHEAD

K-Number: K840408 · 1984-04-25

ApplicantAdr Ultrasound
Decision Date1984-04-25
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LINEAR ARRAY TRANSDUCER OR SCANHEAD is the device name listed in this FDA 510(k) record. The listed applicant is Adr Ultrasound. It received FDA 510(k) clearance on 1984-04-25 under 510(k) number K840408. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINEAR ARRAY TRANSDUCER OR SCANHEAD?

LINEAR ARRAY TRANSDUCER OR SCANHEAD is a medical device that received FDA 510(k) clearance on 1984-04-25. The listed applicant is Adr Ultrasound. The 510(k) number is K840408.

When did LINEAR ARRAY TRANSDUCER OR SCANHEAD receive FDA 510(k) clearance?

LINEAR ARRAY TRANSDUCER OR SCANHEAD received FDA 510(k) clearance on 1984-04-25, under 510(k) number K840408.

Who is the listed applicant for LINEAR ARRAY TRANSDUCER OR SCANHEAD?

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

What is the FDA product code for LINEAR ARRAY TRANSDUCER OR SCANHEAD?

The FDA product code for LINEAR ARRAY TRANSDUCER OR SCANHEAD is IYO.

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Other records listing Adr Ultrasound 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.

K834141ULTRASOUND SCAN HEAD 3.5 MHZK833224BIFOCAL 3.0MHZK828049ADR ULTRASOUND MC2 LARGE CARTK828053ADR ULTRASOUND 5.5 MHZ SHORT FOCUS TRANSDUCERK828051ADR ULTRASOUND MODEL 4000 SC OR 4000 S/LCK828050ADR ULTRASOUND MODEL 4000 L

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Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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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