FDA 510(k)

MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15

K-Number: K920071 · 1992-07-21

Decision Date1992-07-21

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Devices, Inc.. It received FDA 510(k) clearance on 1992-07-21 under 510(k) number K920071. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15?

MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15 is a medical device that received FDA 510(k) clearance on 1992-07-21. The listed applicant is Medical Devices, Inc.. The 510(k) number is K920071.

When did MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15 receive FDA 510(k) clearance?

MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15 received FDA 510(k) clearance on 1992-07-21, under 510(k) number K920071.

Who is the listed applicant for MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15?

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

What is the FDA product code for MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15?

The FDA product code for MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15 is GEI.

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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.