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FDA 510(k)

SIGMA M

K-Number: K063837 · 2007-07-02

ApplicantInstrumentarium Dental, Palodex Group OY
Decision Date2007-07-02
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SIGMA M is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentarium Dental, Palodex Group OY. It received FDA 510(k) clearance on 2007-07-02 under 510(k) number K063837. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA M?

SIGMA M is a medical device that received FDA 510(k) clearance on 2007-07-02. The listed applicant is Instrumentarium Dental, Palodex Group OY. The 510(k) number is K063837.

When did SIGMA M receive FDA 510(k) clearance?

SIGMA M received FDA 510(k) clearance on 2007-07-02, under 510(k) number K063837.

Who is the listed applicant for SIGMA M?

The FDA 510(k) record lists Instrumentarium Dental, Palodex Group OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGMA M?

The FDA product code for SIGMA M is MUH.

Related Clinical Trials

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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Other records listing Instrumentarium Dental, Palodex Group OY 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.

K093683ORTHOPANTOMOGRAPH OP300K092591ORTHOPANTOMOGRAPH OP30K081925SNAPSHOT

Related Devices (Code: MUH)

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

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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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