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FDA 510(k)

MICRO MAMMO I MAMMOGRAPHY UNIT

K-Number: K871048 · 1987-09-01

ApplicantAmerasia Import-Export, Inc.
Decision Date1987-09-01
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MICRO MAMMO I MAMMOGRAPHY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Amerasia Import-Export, Inc.. It received FDA 510(k) clearance on 1987-09-01 under 510(k) number K871048. 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 MICRO MAMMO I MAMMOGRAPHY UNIT?

MICRO MAMMO I MAMMOGRAPHY UNIT is a medical device that received FDA 510(k) clearance on 1987-09-01. The listed applicant is Amerasia Import-Export, Inc.. The 510(k) number is K871048.

When did MICRO MAMMO I MAMMOGRAPHY UNIT receive FDA 510(k) clearance?

MICRO MAMMO I MAMMOGRAPHY UNIT received FDA 510(k) clearance on 1987-09-01, under 510(k) number K871048.

Who is the listed applicant for MICRO MAMMO I MAMMOGRAPHY UNIT?

The FDA 510(k) record lists Amerasia Import-Export, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICRO MAMMO I MAMMOGRAPHY UNIT?

The FDA product code for MICRO MAMMO I MAMMOGRAPHY UNIT 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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