FDA 510(k)

VARIABLE FOCUS 3.5 MHZ TRANSDUCER

K-Number: K812301 · 1981-11-16

Decision Date1981-11-16

Product CodeITX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

VARIABLE FOCUS 3.5 MHZ TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Adr Ultrasound. It received FDA 510(k) clearance on 1981-11-16 under 510(k) number K812301. 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 VARIABLE FOCUS 3.5 MHZ TRANSDUCER?

VARIABLE FOCUS 3.5 MHZ TRANSDUCER is a medical device that received FDA 510(k) clearance on 1981-11-16. The listed applicant is Adr Ultrasound. The 510(k) number is K812301.

When did VARIABLE FOCUS 3.5 MHZ TRANSDUCER receive FDA 510(k) clearance?

VARIABLE FOCUS 3.5 MHZ TRANSDUCER received FDA 510(k) clearance on 1981-11-16, under 510(k) number K812301.

Who is the listed applicant for VARIABLE FOCUS 3.5 MHZ TRANSDUCER?

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 VARIABLE FOCUS 3.5 MHZ TRANSDUCER?

The FDA product code for VARIABLE FOCUS 3.5 MHZ TRANSDUCER is ITX.

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Other records listing Adr Ultrasound as applicant

K840408LINEAR ARRAY TRANSDUCER OR SCANHEAD K834141ULTRASOUND SCAN HEAD 3.5 MHZ K833224BIFOCAL 3.0MHZ K828051ADR ULTRASOUND MODEL 4000 SC OR 4000 S/LC K828053ADR ULTRASOUND 5.5 MHZ SHORT FOCUS TRANSDUCER K828050ADR ULTRASOUND MODEL 4000 L

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Related Devices (Code: ITX)

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm Corporation K254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLC K261014Accuro® 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.