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FDA 510(k)

MAMMOTEST PRODUCT, MODIFICATION

K-Number: K926575 · 1993-03-30

Decision Date1993-03-30
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MAMMOTEST PRODUCT, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Fischer Imaging Corp.. It received FDA 510(k) clearance on 1993-03-30 under 510(k) number K926575. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAMMOTEST PRODUCT, MODIFICATION?

MAMMOTEST PRODUCT, MODIFICATION is a medical device that received FDA 510(k) clearance on 1993-03-30. The listed applicant is Fischer Imaging Corp.. The 510(k) number is K926575.

When did MAMMOTEST PRODUCT, MODIFICATION receive FDA 510(k) clearance?

MAMMOTEST PRODUCT, MODIFICATION received FDA 510(k) clearance on 1993-03-30, under 510(k) number K926575.

Who is the listed applicant for MAMMOTEST PRODUCT, MODIFICATION?

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

What is the FDA product code for MAMMOTEST PRODUCT, MODIFICATION?

The FDA product code for MAMMOTEST PRODUCT, MODIFICATION is EHD.

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.

Other records listing Fischer 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.

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Related Devices (Code: EHD)

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.

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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