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FDA 510(k)

EXOMIO, MODEL 2.0 SP1

K-Number: K032550 · 2003-09-25

ApplicantMedcom GmbH
Decision Date2003-09-25
Product CodeKPQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXOMIO, MODEL 2.0 SP1 is the device name listed in this FDA 510(k) record. The listed applicant is Medcom GmbH. It received FDA 510(k) clearance on 2003-09-25 under 510(k) number K032550. 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 2.0 SP1?

EXOMIO, MODEL 2.0 SP1 is a medical device that received FDA 510(k) clearance on 2003-09-25. The listed applicant is Medcom GmbH. The 510(k) number is K032550.

When did EXOMIO, MODEL 2.0 SP1 receive FDA 510(k) clearance?

EXOMIO, MODEL 2.0 SP1 received FDA 510(k) clearance on 2003-09-25, under 510(k) number K032550.

Who is the listed applicant for EXOMIO, MODEL 2.0 SP1?

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 2.0 SP1?

The FDA product code for EXOMIO, MODEL 2.0 SP1 is KPQ.

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Other records listing Medcom GmbH as applicant

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Related Devices (Code: KPQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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