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FDA 510(k)

MEDONIC M SERIES

K-Number: K083420 · 2009-02-03

ApplicantBoule Medical AB
Decision Date2009-02-03
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MEDONIC M SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Boule Medical AB. It received FDA 510(k) clearance on 2009-02-03 under 510(k) number K083420. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDONIC M SERIES?

MEDONIC M SERIES is a medical device that received FDA 510(k) clearance on 2009-02-03. The listed applicant is Boule Medical AB. The 510(k) number is K083420.

When did MEDONIC M SERIES receive FDA 510(k) clearance?

MEDONIC M SERIES received FDA 510(k) clearance on 2009-02-03, under 510(k) number K083420.

Who is the listed applicant for MEDONIC M SERIES?

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

What is the FDA product code for MEDONIC M SERIES?

The FDA product code for MEDONIC M SERIES is GKZ.

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Other records listing Boule Medical AB as applicant

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.

K032214MEDONIC CA620/530 HEMATOLOGY ANALYZER

Related Devices (Code: GKZ)

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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