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FDA 510(k)

BIOPSY ATTACHMENT;DYNEX ULTRASOUND-

K-Number: K840451 · 1984-05-09

ApplicantElscint, Inc.
Decision Date1984-05-09
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BIOPSY ATTACHMENT;DYNEX ULTRASOUND- is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1984-05-09 under 510(k) number K840451. 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 BIOPSY ATTACHMENT;DYNEX ULTRASOUND-?

BIOPSY ATTACHMENT;DYNEX ULTRASOUND- is a medical device that received FDA 510(k) clearance on 1984-05-09. The listed applicant is Elscint, Inc.. The 510(k) number is K840451.

When did BIOPSY ATTACHMENT;DYNEX ULTRASOUND- receive FDA 510(k) clearance?

BIOPSY ATTACHMENT;DYNEX ULTRASOUND- received FDA 510(k) clearance on 1984-05-09, under 510(k) number K840451.

Who is the listed applicant for BIOPSY ATTACHMENT;DYNEX ULTRASOUND-?

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

What is the FDA product code for BIOPSY ATTACHMENT;DYNEX ULTRASOUND-?

The FDA product code for BIOPSY ATTACHMENT;DYNEX ULTRASOUND- is IYO.

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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.

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