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FDA 510(k)

ADR ULTRASOUND MODELS 4000S & 4000S/L

K-Number: K813543 · 1982-02-24

ApplicantAdr Ultrasound
Decision Date1982-02-24
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ADR ULTRASOUND MODELS 4000S & 4000S/L is the device name listed in this FDA 510(k) record. The listed applicant is Adr Ultrasound. It received FDA 510(k) clearance on 1982-02-24 under 510(k) number K813543. 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 ADR ULTRASOUND MODELS 4000S & 4000S/L?

ADR ULTRASOUND MODELS 4000S & 4000S/L is a medical device that received FDA 510(k) clearance on 1982-02-24. The listed applicant is Adr Ultrasound. The 510(k) number is K813543.

When did ADR ULTRASOUND MODELS 4000S & 4000S/L receive FDA 510(k) clearance?

ADR ULTRASOUND MODELS 4000S & 4000S/L received FDA 510(k) clearance on 1982-02-24, under 510(k) number K813543.

Who is the listed applicant for ADR ULTRASOUND MODELS 4000S & 4000S/L?

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 ADR ULTRASOUND MODELS 4000S & 4000S/L?

The FDA product code for ADR ULTRASOUND MODELS 4000S & 4000S/L 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.

K840408LINEAR ARRAY TRANSDUCER OR SCANHEADK834141ULTRASOUND SCAN HEAD 3.5 MHZK833224BIFOCAL 3.0MHZK828053ADR 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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