FDA 510(k)

ULTRASOUND SCAN HEAD 3.5 MHZ

K-Number: K834141 · 1984-04-20

Decision Date1984-04-20

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ULTRASOUND SCAN HEAD 3.5 MHZ is the device name listed in this FDA 510(k) record. The listed applicant is Adr Ultrasound. It received FDA 510(k) clearance on 1984-04-20 under 510(k) number K834141. 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 ULTRASOUND SCAN HEAD 3.5 MHZ?

ULTRASOUND SCAN HEAD 3.5 MHZ is a medical device that received FDA 510(k) clearance on 1984-04-20. The listed applicant is Adr Ultrasound. The 510(k) number is K834141.

When did ULTRASOUND SCAN HEAD 3.5 MHZ receive FDA 510(k) clearance?

ULTRASOUND SCAN HEAD 3.5 MHZ received FDA 510(k) clearance on 1984-04-20, under 510(k) number K834141.

Who is the listed applicant for ULTRASOUND SCAN HEAD 3.5 MHZ?

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 ULTRASOUND SCAN HEAD 3.5 MHZ?

The FDA product code for ULTRASOUND SCAN HEAD 3.5 MHZ is IYO.

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Other records listing Adr Ultrasound as applicant

K840408LINEAR ARRAY TRANSDUCER OR SCANHEAD K833224BIFOCAL 3.0MHZ K828049ADR ULTRASOUND MC2 LARGE CART K828053ADR ULTRASOUND 5.5 MHZ SHORT FOCUS TRANSDUCER K828051ADR ULTRASOUND MODEL 4000 SC OR 4000 S/LC K828050ADR ULTRASOUND MODEL 4000 L

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Related Devices (Code: IYO)

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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.