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FDA 510(k)

MAMMOGRAPH III

K-Number: K844119 · 1985-07-19

ApplicantAmerican Medical Imports, Inc.
Decision Date1985-07-19
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMMOGRAPH III is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Imports, Inc.. It received FDA 510(k) clearance on 1985-07-19 under 510(k) number K844119. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAMMOGRAPH III?

MAMMOGRAPH III is a medical device that received FDA 510(k) clearance on 1985-07-19. The listed applicant is American Medical Imports, Inc.. The 510(k) number is K844119.

When did MAMMOGRAPH III receive FDA 510(k) clearance?

MAMMOGRAPH III received FDA 510(k) clearance on 1985-07-19, under 510(k) number K844119.

Who is the listed applicant for MAMMOGRAPH III?

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

What is the FDA product code for MAMMOGRAPH III?

The FDA product code for MAMMOGRAPH III is IZH.

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Related Devices (Code: IZH)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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