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FDA 510(k)

MAMEX

K-Number: K992037 · 1999-07-30

ApplicantDel Medical Imaging Corp.
Decision Date1999-07-30
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMEX is the device name listed in this FDA 510(k) record. The listed applicant is Del Medical Imaging Corp.. It received FDA 510(k) clearance on 1999-07-30 under 510(k) number K992037. 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 MAMEX?

MAMEX is a medical device that received FDA 510(k) clearance on 1999-07-30. The listed applicant is Del Medical Imaging Corp.. The 510(k) number is K992037.

When did MAMEX receive FDA 510(k) clearance?

MAMEX received FDA 510(k) clearance on 1999-07-30, under 510(k) number K992037.

Who is the listed applicant for MAMEX?

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

What is the FDA product code for MAMEX?

The FDA product code for MAMEX is IZH.

Related Clinical Trials

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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Other records listing Del Medical Imaging Corp. as applicant

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.

K063188DEL-IMS

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.

K203509SMART FINDERIms Giotto S.P.A.K202294Affirm Contrast BiopsyHologic, Inc.K191495Biopsy PositionerFujifilm CorporationK161575Affirm Lateral Arm Upright Biopsy AccessoryHologicK161920Comfort CoverPrecision Dynamics CorporationK153486Affirm Prone Biopsy SystemHologic, Inc.

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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