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FDA 510(k)

MAMMOGRAPH MAMMOGRAPHIC X-RAY DEVICE

K-Number: K872734 · 1987-10-08

ApplicantPalomex Instrumentarium Corp.
Decision Date1987-10-08
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMMOGRAPH MAMMOGRAPHIC X-RAY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Palomex Instrumentarium Corp.. It received FDA 510(k) clearance on 1987-10-08 under 510(k) number K872734. 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 MAMMOGRAPHIC X-RAY DEVICE?

MAMMOGRAPH MAMMOGRAPHIC X-RAY DEVICE is a medical device that received FDA 510(k) clearance on 1987-10-08. The listed applicant is Palomex Instrumentarium Corp.. The 510(k) number is K872734.

When did MAMMOGRAPH MAMMOGRAPHIC X-RAY DEVICE receive FDA 510(k) clearance?

MAMMOGRAPH MAMMOGRAPHIC X-RAY DEVICE received FDA 510(k) clearance on 1987-10-08, under 510(k) number K872734.

Who is the listed applicant for MAMMOGRAPH MAMMOGRAPHIC X-RAY DEVICE?

The FDA 510(k) record lists Palomex Instrumentarium Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAMMOGRAPH MAMMOGRAPHIC X-RAY DEVICE?

The FDA product code for MAMMOGRAPH MAMMOGRAPHIC X-RAY DEVICE is IZH.

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Related Devices (Code: IZH)

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.

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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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