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FDA 510(k)

MAMEX DC AMI SL12/MG15

K-Number: K905748 · 1991-03-07

ApplicantSoredex, Inc.
Decision Date1991-03-07
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMEX DC AMI SL12/MG15 is the device name listed in this FDA 510(k) record. The listed applicant is Soredex, Inc.. It received FDA 510(k) clearance on 1991-03-07 under 510(k) number K905748. 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 DC AMI SL12/MG15?

MAMEX DC AMI SL12/MG15 is a medical device that received FDA 510(k) clearance on 1991-03-07. The listed applicant is Soredex, Inc.. The 510(k) number is K905748.

When did MAMEX DC AMI SL12/MG15 receive FDA 510(k) clearance?

MAMEX DC AMI SL12/MG15 received FDA 510(k) clearance on 1991-03-07, under 510(k) number K905748.

Who is the listed applicant for MAMEX DC AMI SL12/MG15?

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

What is the FDA product code for MAMEX DC AMI SL12/MG15?

The FDA product code for MAMEX DC AMI SL12/MG15 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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