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FDA 510(k)

EXOMIO, MODEL 1.1

K-Number: K022219 · 2002-10-07

ApplicantMedcom GmbH
Decision Date2002-10-07
Product CodeKPQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXOMIO, MODEL 1.1 is the device name listed in this FDA 510(k) record. The listed applicant is Medcom GmbH. It received FDA 510(k) clearance on 2002-10-07 under 510(k) number K022219. The device is classified under product code KPQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXOMIO, MODEL 1.1?

EXOMIO, MODEL 1.1 is a medical device that received FDA 510(k) clearance on 2002-10-07. The listed applicant is Medcom GmbH. The 510(k) number is K022219.

When did EXOMIO, MODEL 1.1 receive FDA 510(k) clearance?

EXOMIO, MODEL 1.1 received FDA 510(k) clearance on 2002-10-07, under 510(k) number K022219.

Who is the listed applicant for EXOMIO, MODEL 1.1?

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

What is the FDA product code for EXOMIO, MODEL 1.1?

The FDA product code for EXOMIO, MODEL 1.1 is KPQ.

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Related Devices (Code: KPQ)

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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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