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FDA 510(k)

MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.

K-Number: K884676 · 1989-01-06

ApplicantElscint, Inc.
Decision Date1989-01-06
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI. is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1989-01-06 under 510(k) number K884676. 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 MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.?

MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI. is a medical device that received FDA 510(k) clearance on 1989-01-06. The listed applicant is Elscint, Inc.. The 510(k) number is K884676.

When did MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI. receive FDA 510(k) clearance?

MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI. received FDA 510(k) clearance on 1989-01-06, under 510(k) number K884676.

Who is the listed applicant for MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.?

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 MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.?

The FDA product code for MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI. is IZH.

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Other records listing Elscint, Inc. as applicant

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Related Devices (Code: IZH)

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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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